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45 Cards in this Set

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  • Back
Describe ADME/Tox and how these 4 criteria influence the drug level and pharmacological activity of a drug candidate.
(1)Adsorption-How does the drug enter the body-reach the plasma?
(2)Distribution-Where does the drug go in the body after it has been absorbed (plasma)?
(3)Metabolism-How is the drug changed by the body (ie. the liver)?
(4)Elimination-The route by which the drug metabolites leave the body.
Purpose of an IND (Investigational New Drug Application)
To provide data showing that it is reasonable to begin tests of a new drug on humans
3 Areas of Preclinical Data Submitted to the FDA
(1)Animal Pharmacology and Toxicology Studies (ADME/Tox)
(2)Manufacturing Information-Can the company produce the product as a medecine?
(3)Clinical Protocols and Investigator Information
3 Components of Toxicity
(1)a pharmacological profile of the drug in living cells/animals
(2)drug toxicity studies in at least 2 species of animals
(3)short-term toxicity studies ranging from 2 weeks to 3 months
When must the FDA make their decision after the IND is submitted?
30 days after receipt
Gives either a "safety acceptable to proceed" or a "clinical hold decision"
Clinical Hold Decision
The CDER can't confirm that the study can be conducted w/o unreasonable risk to the subjects/patients.
Will likely stop the clinical trial!
Early Research/Preclinical Testing
Years: 6.5
Test Pop: Lab and animal studies
Purpose: Assess safety and biological activity
Success Rate: 5,000 compounds evaluated
Phase I Trials
Test Pop: 20-80 healthy volunteers
Purpose: Determine safety and dosage.
Phase II Trials
Years: 2
Test Pop: 100-300 patient volunteers
Purpose: Evaluate effectiveness and look for side effects
Phase III Trials
Years: 3.5
Test Pop: 1000-3000 patient volunteers
Purpose: Confirm effectiveness and monitor adverse reactions from long-term use
FDA (involvement in Trials)
Years: 1.5
Purpose: Review Process/Approval
Success Rate: 1 approved
Phase IV Trials
Purpose: Additional Post-Marketing Testing required by the FDA
Test Pop: Patient subgroups/population
Cost to Develop a New Med
1. $802 M
2. $51.3B spent on R$D
Discovery Research
Cost: $155-225 M
Time: 5.5yrs.
-Lead Compound Screening
-Discovery Testing
-Stability and Formulation
Cost: $65-90M
Years: 4
-Filing for Patent Protection "First to Invent"
Inclusion Criteria
Factors that allow you to participate in a clinical trial
Exclusion Criteria
Factors that keep you from participating in a clinical trial
Purpose of Inclusion/Exclusion Criteria
-Identify the right ppl and keep them safe!
-Guidlines include age, type of disease, medical history, current med condition
3 routes to get a drug to the bloodstream
1. Parenteral (SubQ, IV, IM)
2. Oral (Enteral)
3. Pulmonary
1. Professionally Administered
2. Compliance
3. 100% Bioavailability
1. Fear of Needles
2. Sterile Conditions Required
3. Invasive/Infection
Oral (Enteral)
1. Inexpensive Formulation
2. Easy to take; Flexible Options
3. Pills, tablets, liquids, enteric coated
1. First Pass Metabolism
2. Compliance
3. Solubility
1. Quick entry into the bloodstream
2. Large surface area
3. Non-invasive
1. Lung inflammation
2. Poor Dosage control
Types of Drug Delivery Developed by Alza
1. OROS Oral Delivery
2. D-Trans (Transdermal)
3. STEALTH Liposomes
4. DUROS implants
5. E-Trans (Transdermal +!)
6. Macroflux
OROS Oral Delivery`
-push compartment that swells with water to slowly release the drug
-controlled drug delivery up to 24 hrs.
-for liquids or 2 diff drugs/concentrations
ie. concerta for 12h adhd control
D-Trans (Transdermal)
-Patch: backing layer, drug reservoir, rate-controlling film, and an adhesive
-releases drugs at a controlled rate over one day
ie. nicoderm
STEALTH Liposomes
-Liposomes are recognized by the immune system and often destroyed before significant amounts of drug can reach the intended disease site.
STEALTH liposomes evade immune system by PEGylation
Doxil (Adriamycin)
DUROS implants
-Titanium implant placed under the skin of a patient’s upper arm with an osmotic engine / piston
-Viadur: For prostate cancer. Releases leuprolide acetate, which reduces the amount of testosterone produced by the testicles to treat the symptoms of advanced prostate cancer. Viadur releases leuprolide acetate for 12 months
E-Trans (Transdermal +)
-Electrotransport technology = Low-level electrical energy to actively transport drugs through intact skin
-Patient-controlled transdermal delivery =self-administer up to six times per hour.
E-TRANS Fentanyl
Microneedle Array
3 processes that speed up NDA consideration and FDA approval
1. Fast Track
2. P-(priority) Designation
3. Accelerated Approval
Fast Track
Investigators work closely with the FDA; can submit individual parts of the NDA to the FDA one at a time to speed approval
Priority Designation (S)
S - Standard review for drugs similar to currently available drugs - offer only minor improvement (or none) over drugs already on the market.
The FDA has 60 days to accept or reject the NDA for review,
FDA action at ~10 months
Priority Designation (P)
-For drugs that represent potential major advances in health care - reserved for products that address unmet medical needs
-The FDA has 45 days to accept or reject the NDA for review
-FDA action not later than 6 months.
-"The "PDUFA clock" starts on the day the NDA is filed with the FDA. Biotech firms typically issue press releases when drugs are filed, so it's relatively easy for investors to count forward six months from that day to find the date by which the FDA must issue its decision, often referred to as the "PDUFA date."
Accelerated Review
For serious or life-threatening illnesses, or for illnesses for which no therapy exists or a significant advantage over existing drugs.
-Puting the drug up for early review after establishing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, rather than the primary endpoint originally proposed in the study.
Approval is granted even though there may be some "uncertainty as to the relation of that endpoint to clinical benefit... BUT the sponsor MUST agree to conduct post approval studies and to accept expedited procedures to remove drugs when the further studies failed to confirm effectiveness.
Surrogate Endpoint
that reasonably predict that a drug provides clinical benefit (ie: approving drugs to prevent strokes (primary endpoint) on the basis of evidence that they lower blood pressure, OR a drug to extend survival of breast cancer patients (primary endpoint) if clinical trials reveal that the drug has an ability to shrink tumors dramatically, within 4 weeks of receiving the drug.
Compassionate Access
An alternative to clinical trials for desperately ill patients.

Access to experimental medications before the drug has approval, to save the life of a critically ill patient.
Procedure: M.D. applies to the pharmaceutical company and FDA via a Treatment IND; approval considered on a case-by-case basis. Criteria:

Advanced / Serious / life-threatening disease
No approved treatment options / undergone all standard treatments without success.
No appropriate clinical trial options (or patient does not substantially satisfy entry criteria).
However, if designed well, a compassionate access program can produce enough data to help the drug win FDA approval.
The company usually has valid reasons for refusing compassionate access - giving an experimental drug to a few people before it is proved wastes resources, time, and money (and the drug itself) that could be spent on determining whether the drug works.
Orphan Drug Act
Encourages development of new drugs for the treatment of rare diseases, such as Huntington's disease, ALS (Lou Gehrig's disease), Tourette syndrome, and muscular dystrophy, Gaucher's disease.
Afflict so few patients (<200,000) - not economically feasible for pharmaceutical companies to compete in these markets.

The ODA provides 4 financial incentives
1.) Tax Credits for the cost of clinical research.
2.) Government grant funding.
3.) Assistance for clinical research.
4.) Seven years of exclusive marketing for the first sponsor that passed through the FDA!
Rule of 72
To find the number of years required to double your money at a given interest rate, you just divide the interest rate into 72. For example, if you want to know how long it will take to double your money at eight percent interest, 72 / 8 = 9 years! If you have a goal of doubling your money in 5 years, then you'd better be prepared to find an investment vehicle earning ______% / year!
Characteristics of Companies Worth Your Investment Dollar(Motley Fool)
(1)Powerful brands. 'Coca-Cola (NYSE: KO), PepsiCo (NYSE: PEP), GE (NYSE: GE), Nokia (NYSE: NOK), McDonald's (MCD), Ford (NYSE: F), and Disney (NYSE: DIS)'.
(2)Significant products or services. 'Firms selling things people really need or really want. Pharmaceuticals = people will buy whether they're flush with funds or strapped for cash. Harley-Davidson (NYSE: HDI) and Starbucks (Nasdaq: SBUX) offer consumers things they love.
(3)Strong competitive position. 'Advantages over its peers = brand value, economies of scale (making so much that costs / item are low), and bargaining power. Wal-Mart (NYSE: WMT),is so big that it can boss its suppliers around.'
(4)Consistent, reliable earnings, sales, and profit margins. Look for sales and earnings to have increased steadily over past years, reflecting capable management. See who's wringing the most value out of each dollar of sales. Stock splits
(5)Lots of potential. A stellar past isn't enough. Make sure the company has great potential for growth. Is it expanding abroad? Is it coming out with promising new products or services? Are its offerings taking consumers by storm? Is it spending significantly on research and development?
The first sale of stock to the public, authorized (sanctioned) by the SEC. It is a way for a company to raise money to grow or continue to fund their operation - and they don't have to get it from borrowing money or VC! The tradeoff: Once a company goes public, it then has to share its profit with investors, has to be accountable to shareholders, and
has to provide an annual report to stockholders, and the public, about its operations.
Myeloma Cells
cancerous B-cells with unlimited growth that have lost the ability to make their own antibodies
-have unlimited proliferation!
Purpose of Immunized Mouse in Making Monoclonal Antibodies
a single antibody-secreting B cell (from the spleen of a mouse immunized with the target protein)
fused B-cell: myeloma cells
Fully Humanized Monoclonal Antibody
has the antigen binding murine complementarity-determining regions interspersed within the variable regions of the light (light gray) and heavy (dark gray) chains of the Fab portion of the engineered antibody.
Chimeric Monoclonal Antibody
the entire antigen-binding murine component of the variable region of the Fab section is maintained integrally