Pharmaceutics Exam 2

Front 1

Separation between Medicine and Pharmacy

Back 1

Germany in 1240 AD

Front 2

Pure Food and Drug Act of 1906

Back 2

Concerned with labeling drugs, quality, strength, and purity

Front 3

Food, Drug, and Cosmetic Act of 1938

Back 3

Concerned with drug safety

Front 4

USP-NF

Back 4

Combine USP and National Formulary

Front 5

OBRA 90

Back 5

Therapeutic Counseling of Pharmacist

Front 6

NDA

Back 6

New Drug Application

Front 7

FDA

Back 7

Food and Drug Administration

Front 8

IND

Front 9

ISO

Back 9

International Organization for the Standardization

Front 10

Year of 1st USP

Back 10

1820 – USP XX – NF XV

Front 11

NF

Back 11

National Formulary of Unofficial Preparations

Front 12

USP

Back 12

United States Pharmacoepia – drugs with therapeutic merit

Front 13

Durham-Humphrey Amendment (1952)

Back 13

Classification of prescription and no prescription drugs

Front 14

Kefauver and Harris Amendments (1962)

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Drug companies had to vouch for safety and efficacy or FDA could withdraw drug from market

Front 15

Drug Listing Act (1972)

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Drug firm that maunfactures or repackages drugs including imported drugs for ultimate sale or distribution (EXCEPT IN_PATIENT) must register with FDA

Front 16

ISO

Back 16

International Organization for the Standardization - standards for development, production, QA, QC, QM, detection of defective products, product safety, and liability

Front 17

Year of 1st USP

Back 17

1820 – USP XX – NF XV

Front 18

NF

Back 18

National Formulary of Unofficial Preparations

Front 19

USP

Back 19

United States Pharmacoepia – drugs with therapeutic merit

Front 20

Typical monograph of a drug in USP

Back 20

Official title, Structural/Empirical Formula, MW, Chemical Name, CAS registry number

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NDC

Back 21

3 segment, 10 digit number (labeler, product, trade package size)

Front 22

is that component of pharmacy practice which entails the direct interaction of the pharmacist with the patient for the purpose of caring for that patient’s drug-related needs

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Pharmaceutical Care

Front 23

Mission of Pharmacy

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to serve society as the profession responsible for the appropriate use of medications, device, and service to achieve optimal therapeutic outcomes

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lead compound

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a prototype chemical compound that has a fundamental
desired biologic or pharmacologic activity – may not have potency,
Absorbability, solubility, low toxicity etc so needs chemical modification

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Prodrug

Back 25

compounds that require metabolic biotransformation
after administration to produce active compounds
(ex. ACE inhibitor to treat hypertension: enalapril maleate (Vasotec) to enalaprilat

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Class I Drug Product Recall

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Reasonable probability of serious adverse health consequences or death (most serious)

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Class II Drug Product Recall

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May cause temporary or medically reversible consequences

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Class III Drug Product Recall

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not likely to cause adverse health consequences (least serious of drug recalls)

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IND

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Investigational New Drug Application

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ANDA

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Abbreviated new drug application - gain approval to market a generic durg that is already approved by original sponsor

Front 31

orphan drugs

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targeted for small numbers of patients who have rare conditions or diseases for which there are no satisfactory alternative treatments

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Treatment IND

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if no satisfactory approved drugs exist for a serious medical condition, treatment IND can be implemented wheree special protocols are issued permitting the use of an investigational drug to treat some patients prior to appoval of the INDA - often sought for orphan drugs

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SNDA

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required for changes in labeling or formulary (supplemental new drug application)

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Preclinical Studies

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Research and Development that lasts usually 6.5 years
it includes short term and some long term testing to discover the inital synthesis and characterization of a drug- followed by FDA 30 day review

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Clinical Research and Development

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includes phase 1, 2, and 3 studies and long term studies. Following clinical development, NDA is submitted to FDA (lasts about 7 years)

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NDA review

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NDA submitted to FDA - takes about 1.5 years

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ANDA does not require

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clinical data on drug safety and efficacy bc is not pioneer drug

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goal drug

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produce specifically desired effect, be administered by the most desired route (generally orally) at minimal dosage and dosing frequency, have optimal onset and duration of activity,e xhibit no side effects and following its desired effect would be eliminated from the body efficiently, completely, and without residual effect