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149 Cards in this Set
- Front
- Back
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What are the pharmaceutical sciences?
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"A group of interdisciplinary areas of study involved with the design, action delivery, disposition (what it goes) and use of drugs"
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What are the most important words in pharmaceutical sciences?
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"Safety, Efficacy and Patient Compliance"
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Sub-Specialties/Branches of Pharmaceutical Sciences
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"Pharmacology, Pharmaceutical/Medicinal Chemistry, Pharmaceutics & Pharmacognosy"
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Branches of Pharmacology
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"Pharmacodynamics, Pharmacokinetics, Pharmaceutical Toxicology, Pharmacogenomics"
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Define Pharmacology
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Study of biochemical and physiological effects of drugs on organisms
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Define Pharmacodynamics
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"'What the drug does to the body'
-study of biochemical & physiological effects of drugs on the body or microorganisms or parasites within/on the body and the mechanisms of drug action and the relationship between drug concentration and effect" |
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Define Pharmacokinetics
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"'What the body does to the drug'
-study of absorption, distribution, metabolism, and excretion (ADME) and factors influencing ADME" |
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What is ADME?
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"Absorption
Distribution Metabolism Excretion" |
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Define Pharmaceutical Toxicology
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"study of adverse/toxic effects of drugs in living organisms. Includes study of: symptoms, mechanisms, treatments and detection of toxicity in humans"
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Define Pharmacogenomics
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"study of the influence of genetic variation on drug response in patients on a drugs efficacy and toxicity
'The response of a person to a drug is inherited from his/her parents' -may help to predict how a patient may respond to a drug with a genetic test" |
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Define Pharmaceutical/Medicinal Chemistry.
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"-the study of drug design
-used to synthesize new drug molecules and to optimize its pharmacology -includes QSAR (Quantitative Structure Activity Relationships) -how functional groups affect drug" |
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What is QSAR?
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"Quantitative Structure Activity Relationships
-correlating the chemical structure with action" |
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Define pharmaceutics.
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"-the study of formulating drug/chemical entity into a dosage form for optimal delivery, stability, pharmacology and patient compliance"
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Define pharmacognosy.
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"-the study of the physical, chemical, biochemical and biological properties of drugs, drug substances or potential drugs of natural origin
-search for new drugs from natural sources" |
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Define drugs.
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"""articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals"" AND
""articles (other than food) intended to affect the structure or any fcn of the body of man or other animals"" -legal definition: USFDA - federal food, drug and cosmetic act 1938" |
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What is the ideal drug?
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"-desirable pharmacological action
-selectivity and specificity -few or no side effects -bioavailability -excretion/elimination" |
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Define selectivity.
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"-selective for certain sub group within dose range
ex. if Drug X selects A 80% and B 20%, Drug X is Selective for A ex. yohimbine - selective for receptor within a dose range" |
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Define specificity.
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"-acts only on that receptor
ex. if Drug X acts 100% A and 0% on B, then it is specific for A" |
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Define bioavailability.
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-how much dose/concentration of drug is available to bind at target site
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List the routes of drug administration.
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"3 routes
enteral parenteral topical" |
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What is enteral drug administration?
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"-drug administration by mouth, then excreted"
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What is parentral drug administration?
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-drug administration via injection or infusion
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What is topical drug administration?
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-drug administration on the surface (skin and mucus)
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What are the pros of enteral drug administration?
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"-simple process
-self administration, no assistance required -slow action=slow side effects! -dosage for flexibility (solid and liquid)" |
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What are the cons of enteral drug administration?
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"-slow action
-irritant and unpalatable drugs -absorption unpredictable (bioavailability) -unconscious/uncooperative patient -medical conditions (vomiting/diarrhea) -first-pass metabolism -gastric fluid effects (acid/enzymes)"; |
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What are some examples of enteral drug administration forms?,
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-oral (tablets, capsules, liquids)
-feeding tubes -rectal (suppositories) |
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What are some examples of parentral drug administration?,
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-intravenous (vein) ex. many drugs
-intra-arterial (artery) ex. vasodilator -intramuscular (muscle) ex. vaccines, antibiotics -intra-cardiac (heart) ex. adrenalin -subcutaneous (under the skin) ex. insulin -intradermal (into the skin) ex. allergy testing -intra-peritoneal (peritoneal cavity) ex. peritoneal dialysis -transdermal (through the intact skin) ex. opioid patches -trans-mucosal (diffusion through a mucous membrane) ex. sublingual nitroglycerin -inhalational ex. inhalational anesthetics |
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What are the pros of parental drug administration?,
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-unconscious/uncooperative patient
-medical conditions (vomiting/diarrhea) -first-pass metabolism -rapid action -accuracy of dosing |
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What are the cons of parental drug administration?,
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-expensive (high quality requirements)
-may be painful -requires trained professional to administer/monitor -infection at site of administration -injury to nerves and arteries -very stringent quality requirements |
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What are some examples of topical drug administration?,
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-inhalation (asthma medication - acts locally so NOT parentral)
-epicutaneous (allergy testing, topical local anesthesia, ointments, creams, lotions) -intranasal (decongestant nasal sprays) -eye drops/ear drops (antibiotics) |
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How do drugs work?,
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2 ways
Directly - by nature of compound, will work without help ex. antacid neutralizes excess acid Indirectly (MOST drugs) - drug interacts with one or more target biomolecules (receptors) and initiates a sequence of cellular events |
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What are the principles of drug action? (what action do drugs take),
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5 principles
Stimulation (caffine - CNS stimulant) Depression (zolpidem - CNS depressant) Irritation - irritate surface where applied, increase blood flow to site, usually for pain (ex. menthol) Replacement - natural metabolites/hormones (ex. iron - anemia, hormone replacement) Cytotoxic Action - induces cell death (ex. anti cancer drugs, penicillin) |
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Where do drugs come from? (sources of drugs),
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Plant
Animal Mineral/Earth Microbiological Semisynthetic Synthetic Recombinant DNA technology |
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What are some plant sources for drugs?,
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Leaves
Flowers Fruits Seeds Roots Bark Stem |
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What are some animal sources for drugs?,
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Pancreas
Urine (pregnant women) Sheep thyroid Cod liver Anterior pituitary Blood |
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What are some mineral/earth sources for drugs?,
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Iron (ferrous sulfate)
Mercurial salts Zinc Iodine Fluorine Selenium Magnesium trisilicate Aluminum hyroxide Sodium bicarbonate |
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What are some microbiological sources of drugs?,
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Penicillium notatum
Streptomyces griseus Micromonospora Penicillium griseofulvum Streptomyces fradiae |
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What are some sources of semi-synthetic drugs?,
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nucleus of drug obtained from natural source, retained but chemical structure altered
morphine atropine penicillin testosterone |
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What are some synthetic sources for drugs?,
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-Entirely synthesized in lab
nucleus of drug from natural source as well as chemical structure is altered majority of drugs used in clinical practice |
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What is the physical state property of a drug? What is it used for?,
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-solid, liquid (solution, suspension), mass
-important in formulation and delivery of drugs |
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List the types of physical states of a drug molecule.,
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5 Physical States
Amorphous solid Crystalline solid Hygroscopic solid Liquid Gas |
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What is an amorphous solid?,
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-physical state of a drug
-no defined physical structure -disordered arrangement of molecules |
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What is the role of the FDA, in terms of drugs?
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The Federal Food, Drug and Cosmetic Act, 1938 requires a new drug to be approved by the FDA to be marketed in the USA"" (any/all drugs)
-applies to domestically manufactured as well as imported drugs |
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What must a drug's sponsor (pharmaceutical company) demonstrate to the FDA in order to get a drug approved? (basics),
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-safety and efficacy of the new drug through scientific evidence
-processes used during the development, manufacturing, analysis, packaging and labeling are well controlled and validated |
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List the organizations of the FDA,
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United States Food and Drug Administration
Office of Regulatory Affairs Center for Food Safety and Applied Nutrition National Center for Toxicological Research Center for Devices and Radiological Health Center for Veterinary Medicine Center for Biologic Evaluation and Research Center for Drug Evaluation and Research - Offices of Pharmaceutical Sciences, New Drugs, and Management" |
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What is the most common source for drugs today?
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Synthetic sources
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What are some biosynthetic sources for drugs?
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Recombinant DNA technology - mostly for protein molecules (insulin)
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What is the physical state property of a drug? What is it used for?
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-solid, liquid (solution, suspension), mass
-important in formulation and delivery of drugs |
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List the types of physical states of a drug molecule.
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5 Physical States
Amorphous solid Crystalline solid Hygroscopic solid Liquid Gas |
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What is an amorphous solid?
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-physical state of a drug
-no defined physical structure -disordered arrangement of molecules |
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"What is the role of the FDA, in terms of drugs?"
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""The Federal Food, Drug and Cosmetic Act, 1938 requires a new drug to be approved by the FDA to be marketed in the USA"" (any/all drugs)
-applies to domestically manufactured as well as imported drugs |
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What must a drug's sponsor (pharmaceutical company) demonstrate to the FDA in order to get a drug approved? (basics)
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-safety and efficacy of the new drug through scientific evidence
-processes used during the development, manufacturing, analysis, packaging and labeling are well controlled and validated |
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List the organizations of the FDA
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United States Food and Drug Administration
Office of Regulatory Affairs Center for Food Safety and Applied Nutrition National Center for Toxicological Research Center for Devices and Radiological Health Center for Veterinary Medicine Center for Biologic Evaluation and Research Center for Drug Evaluation and Research - Offices of Pharmaceutical Sciences, New Drugs, and Management |
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The weakest intermolecular bond is____.,Van der Waals
What does CDER stand for? What do they do? |
-Center for Drug Evaluation and Research
regulates most human pharmaceuticals biological products |
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What does CBER stand for? What do they do?
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-Center for Biologic Evaluation and Research
Regulates most human pharmaceuticals Biological Products |
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What organization(s) regulate most human pharmaceuticals and biological products?
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-CDER (center for drug evaluation and research)
-CBER (center for biologic evaluation and research) |
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What does CVM stand for? What do they do?
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-Center for Veterinary Medicine
-Regulates drug products for verinary use |
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What does CDRH stand for? What do they do?
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-Center for Devices and Radiological Health
regulates medical devices regulates radiation emitting devices like cell phones, microwave ovens |
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What does NCTR stand for? What do they do?
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-National Center for Toxicological Research
-Conducts research to define mechanisms of toxicities of products regulated by the FDA |
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What does CFSAN stand for? What do they do?
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-Center for Food Safety and Applied Nutrition
-Regulates food, dietary supplements, and cosmetics |
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What does ORA stand for? What do they do?
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-Office of Regulatory Affairs
-Regulates sites and facilities where human pharmaceuticals are manufactured |
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What were FDA regulations like before 1906?
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-no restriction on labeling
-milk unpasteurized |
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What problems were not addressed in the 1906 Pure Food and Drug Act?
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food or drug standards
false advertising inspection of food and drug manufacturing facilities |
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What happened in the 1937 Elixir of Sulphanilamide?
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-prepared using diethylene glycol=antifreeze as solvent
-administered to children, treat streptococcal infections -patients poisoned, 107 died **existing laws did not require safety testing** |
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"What is the 1938 Federal Food, Drug and Cosmetic Act?"
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-required demonstration of safety for new drugs
-extended controls to cosmetics and devices -provided standards and safe tolerances -authorized factory inspections |
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What is the 1951 Durham-Humphrey Amendment?
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-separation of prescrioption & non-prescription drugs
-defined prescription drugs: those usage for self-medication and which should be used only under a doctor's supervision -required prescription drugs to be labled as 'for sale by prescription only' |
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What happened in the 1961 Thalidomide Disaster?
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-relieved morning sickness syndrome in pregnant women
-unknown it crosses placental wall -Resulted in: Birth defects (deafness, blindness, disfigurement, cleft palette, internal defects) Peripheral neuritis (nerve disorder) |
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What are the 1962 Kefauver-Harris Drug Amendments?
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-drug manufacturers required to prove drug effectiveness and safety to FDA before marketing
-advertisements required to show complete info on benefits/risks -adverse effects required to be reported to the FDA -dramatically increased costs associated with development of new medicines |
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What is the 1970 Comprehensive Drug Abuse Prevention and Control Act?
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-requires pharmaceutical industry to maintain physical security and strict record keeping for drugs with potential for abuse
-provided classification and control lvls based on medical use and potential for abuse |
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What is the 1972 Drug Listing Act?
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-requires drug companies to provide the FDA with a current list of all drugs manufactured for commercial distribution
-drug products identified, reported using National Drug Code (NDC) numbering system -FDA compiles and stores info for easy access -helps to monitor quality of all drugs on the market in the U.S. |
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What is the 1983 Orphan Drug Act?
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-due to increased costs associated with development of new medicines, companies focused on treatments for common diseases (larger market)
-rare disease ignored/'orphaned' -passed to encourage drug development for rare disease (crohn's, hungtington's, tourette's"", provided incentives such as: tax incentives enhanced patent protection, market exclusivities clinical research subsidies creating gov't agencies to carry out R&D activities for orphan drugs (reduce burden on private sector) |
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What is the 1984 Drug Price Competition and Patent Term Restoration Act?
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-aka Hatch-Waxman Act
-provides drug manufacturers a simpler process to file an abbreviated new drug application (ANDA) to market generic versions of a drug -allows 180 day exclusivity to companies that are ""first-to-file"" an ANDA |
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What is the 1987 Prescription Drug Marketing Act?
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-intended to reduce the risk of adulterer, misgranded, repackaged or mislabeled drugs entering USA through 'secondary sources'
-prohibits re-importation of drug manufactured in the U.S., except by the manufacturer -prohibits sell, purchase, trade or reselling of drug samples -samples only to licensed practitioners and pharmacies (written request of practitioner) -manufacturers required to maintain a list of their authorized distributors |
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What is the 1992 Prescription Drug User Fee Act (PDUFA)?
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-allowed the FDA to collect fees from drug manufacturers to fund the new drug approval process
-dont to speed up approval process |
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What were the results of the 1992 Prescription Drug User Fee Act (PDUFA)?
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increased staffing (reviewers)
improved approval times (decision process went from avg. 2 yrs to 45 days) increased number of drug launches improved FDA-industry communication (less rejections) |
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What is the 1994 Dietary Supplement Health and Education Act?
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-addressed the need to regulate the labeling claims made for various herbs and dietary supplements (ex. vitamins, minerals, amino acids, etc.)
ex. Airborne Claim - preventive cure for common cold. Truth - no studies support claim. Conclusion - FTC finds, customers refunded |
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What is the 1997 Food and Drug Administration Modernization Act (FDAMA)?
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-reauthorizes previous acts
-changes the way FDA functions in recognizing advancements in pharmaceutical technology -Major Provision: Reauthorize PDUFA (prescription drug user fees) -Newer Initiatives: harmonizing & streamlining approval process for drugs and biological products increased patients access to experimental drugs and medical devices patient access to clinical tril databases -info on off-label use (companies can circulate peer-reviewed scientific literature on the off-label indication of the product) -pharmacy compounding (special exemptions for compounded drug products prepared by pharmacists to provide patients with individualized therapies not available commercially) -risk-based regulation of medical devices (post-marketing surveillance of high-risk medical devices) -food safety labeling |
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What are Black Box Warnings (BBWs)?
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-FDA's strongest labeling requirements for high risk medicines (ex. anti-depressants)
-label indicates the drug carries a significant risk of serious or even lift-threatening adverse effects -label to describe this risk to health care professionals and emphasize the need for monitoring of patients started on these drugs |
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What constitutes a drug product recall?
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-FDA has authority to recall a drug product if it finds that the marketed product presents a threat or a potential threat to consumer safety
-depth of recall or lvl of market (e.g. wholesaler, retailer, consumer) depends on the degree of hazard |
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List the classes/degrees of hazards of drug recalls.
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Class I - use or exposure will cause serious adverse health consequences or death
Class II - use or exposure may cause temporary or reversible adverse effects Class III - use or exposure not likely to cause adverse effects |
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What are the requirements of a target drug?
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specific desired effect
administered by most desired route minimal dose and dosing frequency optimal onset and duration of action few/ideally no side effects complete and efficient elimination without any residual effect easily produced at low cost pharmaceutically elegant (nice appearance) physically, chemically and microbiologically stable at various conditions of use, storage and transportation |
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List the methods of drug discovery.
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-Chance discovery
-Carefully designed research screening molecular modifications mechanism based drug design |
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Give some examples of chance discovery of a drug.
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- Penicillin: 1928 Fleming; mold contamination in flu culture petri dish
mold lethal to staphylococcus active substance = penicillin -Viagara (sildenafil citrate): 1989-1992 Pfizer; studies on new compound for angina (heart conditions, BVs constrict) vasodilators, failed angina trials blockbuster drug for ED |
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List the types of research screenings for drug discovery.
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-3 ways of screening for a new drug
Random Nonrandom/targeted screening High Throughput Screening (HTS) |
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What is random drug screening?
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-test a vast library of molecules for biologic activity
-useful to detect an unknown activity -help to narrow down promising molecules for more thorough screening |
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What is nonrandom/targeted drug screening?
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-compounds are screened for a specific activity
-requires accurate screening models -Bioassays: effect and potency against positive and negative controls in-vitro (cell cultures, tissues) in-vivo (animal models) |
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Define in-vivo.
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-experimentation/research using a whole, living organism/animal models
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What is High Throughput Screening (HTS)?
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-rapid screening of hundreds of thousands of compounds
-combinatorial chemistry and computer aided drug design (CADD) generates a huge library of molecules. |
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What are molecular modifications? How do they lead to drug discovery?
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-chemical modification of a compound with known activity, often know as lead compound
-done to improve one or more functionalities -knowledge of QSAR is very useful (quantitative structure activity relationship) |
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What is QSAR?
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-Quantitative Structure Activity Relationship
-relates come property of a compound to a specific structural feature of that compound -gives some estimation of the degree of biological activity expected |
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List the functionalities that molecular modifications for drug delivery are done to improve.
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↑ specificity or selectivity
↑ potency (dose effect relationships - how low of a dose can be given to get same effect) improving rate & extent of absorption (bioavailability) improving half-life (duration in the body) ↓ toxicity & side effects improve physical properties (ex. solubility) |
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Define in-vitro.
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-experimentation/research done using components of an organism that have been isolated from their usual biological surroundings
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What organization(s) regulates drug products for veterinary use?
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-CVM (center for veterinary medicine)
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What organization(s) regulate medical devices and radiation emitting devices?,
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-CDRH (center for devices and radiological health)
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What did the 1906 Pure Food and Drug Act do?,
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-prohibited interstate commerce of misbranded and adulterated foods and drugs
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What is the 1944 Public Health Service (PHS) Act?,
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-licensing and marketing of biological drug products
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What organization(s) regulate sites and facilities where human pharmaceuticals are manufactured?,
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-ORA (office of regulatory affairs)
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What does cGMP stand for?,
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-Current Good Manufacturing Practices
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What does cGCP stand for?,
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-Current Good Clinical Practices
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"What organization(s) regulate food, dietary supplements, and cosmetics?",
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-CFSAN (center for food safety and applied nutrition)
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What organization(s) conduct research to define mechanisms of toxicities of products regulated by the FDA?,
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-NCTR (national center for toxicological research)
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What is mechanism based drug design in regard to drug discovery?
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-designing a molecule to interact with specific biochemical or pathophysiological pathway involved in disease progression
-clear understanding of disease mechanism required -identify target (e.g. receptor, enzyme, metabolic pathway, etc.) -advanced software (computer graphics) can be used to design/modify molecule to fit target |
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What is a lead molecule/compound?
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-prototype chemical with a biological activity
-may not have all the desired qualities of a target drug, may have undesired qualities -modifications to structure result in newer chemical entities -Possible Results: improved properties, different pharmacology |
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What is a prodrug?
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-drug administered in inactive form
-metabolism/biotransformation in body release active drug (PK changes) -typically used to optimize ADME |
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What are the objectives of prodrugs?
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Target specific cell type (ex. cancer)
extend duration of action improve solubility improve chemical stability of therapeutic agent |
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What is a new drug?
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-any drug that is not recognized as being safe and effective in the conditions recommended for its use
-any changes in formulation/processing of a previously approved drug -a combination of 2+ old drugs previously approved individually or if ratio of previously approved combination is changed -newly proposed of previously approved drug: use dose dosing frequency dosage form route of administration |
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What questions are pre-clinical development/evaluations of drug delivery carried out with an intent to answer?
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Does it work?
How can it be delivered? What is its fate in the body? Is it safe? Is the manufacture feasible consistently and within quality standards? |
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List the major aspects of pre-clinical development
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-3 major aspects
Biologic/pharmacologic activity evaluation Pharmacokinetic evaluation Toxicological evaluation |
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What do biologic/pharmacologic activity evaluations of pre-clinical development measure?
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-in-vivo (whole animal studies), different animal species used for different conditions
-cells and tissues -isolated perfused organs |
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What do pharmacokinetic evaluations of pre-clinical development measure?
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-ADME
-done to know the fate of the drug within the body -studies carried out in at least TWO species of animals (ex. rodent and non-rodent) |
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How are pharmacokinetic evaluations of pre-clinical development carried out? What tests are run? What is analyzed?
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-analysis of urine, blood, milk, fecal samples
-autopsy of tissues & organs use of a radioactive label and tracing |
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What are pre-formulation studies?
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-intrinsic physical and chemical properties
-try to determine: solubility determination dissolution rate pKa determination partition coefficient stability drug-excipient compatibility crystal properties and polymorphism particle size, shape and surface area thermal properties n |
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What is an INDA?
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-investigational new drug application
-proposal from a sponsore (typically pharmaceutical company) to the FDA requesting permission for clinical testing of a drug in humans |
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What must an INDA contain?
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animal pharmacology and toxicology
pre-formulation, formulation and manufacturing info clinical protocols and clinical investigator info (doctor, hospital, etc.) |
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Who approves/denies an INDA?,-the FDA
How many days does the FDA have to review an INDA? |
-30 days
-if no objections within 30 days=approved |
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What organization other than the FDA must approve an INDA? What is their approval for?
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-IRB (institutional review board) at clinical trial site
-looking at: ethics, consent, protocols, etc |
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Define clinical trial.
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NIH - ""a prospective biomedical or behavioral research study of human subjects that is deisnged to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices"
Department of Health and Human Services (DHHS) - ""a controlled study involving human subjects that is designed to prospectively evaluate the safety and effectiveness of new drugs or devices or of behavioral interventions"" |
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What information do clinical trials look to obtain? What are the expected outcomes?
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safety
efficacy dose dosing frequency side effects, adverse (severe) effects pharmacokinetics (ADME) pharmacodynamics (how the drug acts, mechanism of action, etc.) addtional benefits |
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What are the types of clinical trials?
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-2 types
Controlled (treatment group vs. controlled group) Randomized (double-blind, single-blind, non-blind) |
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What is a controlled clinical trial?
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-treatment group (receive) vs. controlled group (do not receive treatment)
-volunteers all have similar characteristics (ex. age limit) |
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What are the types of randomized clinical trials?
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-3 types
Double-Blind Single-Blind Non-Blind |
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What is a double-blind randomized clinical trial?
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-researcher/doctor and patient do not know what agent is administered/what the drug contains
-avoid bias and placebo effect |
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What is a non-blind randomized clinical trial?
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-everyone knows what agent is being administered/what the drug contains
-drug not affected by patient's knowledge (no placebo effect) ex. cancer drugs - either kills cancer cells or does not |
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List the phases of clinical trials.
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Phase I trials
Phase II trials Phase III trials NDA & review Drug approval Post marketing surveillance Phase IV trials (not always needed) ANDA OTC drug products |
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What occurs in Phase I clinical trials?
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-FIRST in humans
-healthy volunteers (rarely patients) -approx. 20-100 -up to a yr -Primary Goals understand acute safety dose-range tolerability (how much drug can health person tolerate) adverse rxns (close monitoring) -Success Rate=70% -Important ADME findings useful in optimizing dose, dosage form and/or dosing frequency |
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What are the primary goals of phase I clinical trials?
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understand acute safety
dose-range tolerability adverse rxns (close monitoring) |
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What are pharmacokinetic evaluations trying to determine during pre-clinical development?
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-bioavailability (rate & extent of absorption)
-rate of distribution (k) of drug in body, duration of resident -drug metabolism - where? how? chemistry & pharmacology of metabolites -rate, extent & route of elimination of drug from the body |
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What is the success rate of phase I clinical trials?
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-70%
-failures have low tolerability, side-effects, etc |
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What occurs in Phase II clinical trials?
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-Patients volnteer, must have target disease/illness
-typically 1-2 molecules remaining -100-300 people -up to 2 yrs -double-blind & randomized -Primary Goals: efficacy optimum dose optimum route of administration -Success Rate=40% -ADME findings useful in fine tuning dose, dosage form, and/or dosing frequency |
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Who participates in Phase II clinical trials?
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-patients volunteer
-must have target disease/illness |
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What types of trials are run during phase II?
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double-blind
randomized |
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What is the primary goal of phase II clinical trials?
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efficacy
optimum dose optimum route of administration |
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What is the success rate of Phase II clinical trials?
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-40%
-failures have insufficient efficacy or unacceptable side effects -new drugs typically need to show ↑ efficacy over existing drugs on the market |
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"Which one of these comes first?
1. NDA 2. INDA 3. ANDA" |
Answer: 2. INDA
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What is the preclinical evaluation/development as part of the drug development process?,
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-to identify if the new chemical compound is safe and effective enough to pursue as a prospective new drug
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If there are no objections to an INDA from the FDA within 30 days, is the application approved, denied, or neither?
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Approved
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What is a single-blind randomized clinical trial?,
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-patient does not know what agent is being administered/what the drug contains
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How many people participate in phase II clinical trials?,
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100-300 people
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How long do phase II clinical trials last?
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up to 2 yrs
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Who are the participants in phase I trials?,
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-healthy volunteers (rarely patients)
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How many people participate in phase I trials?,
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20-100 volunteers
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How long do phase I trials typically last?,
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up to a year
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What is the most common type of clinical trial - controlled or randomized?,
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-Randomized
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What occurs in Phase III clinical trials?
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-similar to phase II
-longest, most comprehensive trial -diverse group of patients (age, sex, race, disease severity, etc.) -1000-3000 people (multiple national, international locations) -Primary Goals: confirm safety & efficacy closely monitor adverse rxns (long term effects may show up in this phase) -Success Rate=70% |
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When can an NDA be filed with the FDA?
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-after successful completion of 3 phases of clinical trials
-results are compiled, analyzed and submitted to the FDA for review -highly detailed document (approx 100,000 pages) |
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What is contained within a NDA?
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-contains entire history of drug product
preclinical studies animal studies pre-formulation and formulation studies clinical trials manufacturing, quality control, and labeling info (including colors) |
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"T/F - If you know the pKa of a drug and the pH of the aqueous solution of that drug, you can determine the percent ionization of the drug in solution."
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True
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What is the longest and most comprehensive clinical trial phase?
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Phase 3
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"Which of the following routes of administration would result in the highest CSF (cerebrospinal fluid) drug concentration?
Oral Percutaneous Intrathecal Intravenous Rectal" |
Answer: 3. Intrathecal
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