P1 Ceutics

Front 1

-The Federal Food and Drug Act
-Federal Food, Drug and Cosmetic Act
-Kefauver -Harris Drug Amendments
When?

Back 1

1906
1938
1962

Front 2

Federal Food and Drug Act

Back 2

Initial legislation toward food and drug safety

Front 3

Food, Drug and Cosmetic Act

Back 3

Created FDA—safety & efficacy of drug under government control
-No formal distinction between prescription/ non-prescription drugs

Front 4

Kefauver-Harris Amendment

Back 4

Requirement of
Effectiveness

Front 5

difference between the CFR and the FR

Back 5

Code of Federal Regulations(CFR)is a codification of the general and permanent rules published in the Federal Register(FR)by the Executive departments and agencies of the Federal Government

Front 6

Title 21 CFR main requirements

Back 6

Title 21, Part 300 –314 requires a new drug to be approvedby the FDA before it may be legally introduced in interstate commerce.

Front 7

Drug Discovery Resources

Back 7

Natural
Synthetic
Semi-synthetic

Front 8

Methods Of Drug Discovery

Back 8

Random Screens
•Non random Screens
-Bio-assays
-Disease-specific animal models
-High throughput screening
•Molecular Modifications
•Mechanism-Based Drug Design
•Molecular Graphics
•Pharmacogenesis

Front 9

Drug Nomenclature, kinds?

Back 9

Empirical Formula: C14H19Cl2NO2
•Systemic Chemical Name: 4-[bis(2-chloroethyl)amino]-4-[p-[Bis(2-chloroethyl)amino]phenyl]butyric acid
•Nonproprietary name (generic): chlorambucil

Front 10

responsibility of pharmaceutics

Back 10

to find chemical and physical properties that provide a effective and stable product

Front 11

IND Information

Back 11

Safety Evaluation (in animals)
•Any available clinical data
•Adequate drug identification and manufacturing instructions
•Detailed outline of the proposed clinical studies
•Routes of administration
•Approximate number of patients
•Estimate of the length of treatment
•Environmental impact statement (may also be necessary)

Front 12

Drug Approval Process

Back 12

Preclinical
•IND
•Phases I, II, III
•NDA
•Phase IV

Front 13

Bioavailability?
Biological equivalent (Bioequivalent)?

Back 13

The extent and rate of absorption from a dosage form reflected by a time-concentration curve of the administered drug in the systemic circulation
Pharmaceutical Equivalent which, when administered to the same individuals in the same dosage regimen, will result in comparable bioavailability

Front 14

Generics?

Back 14

Take less time to develop
•Same Active Pharmaceutical Excipient
•Bioequivalent
•Different Excipients

Front 15

Orange Book Classifications?

Back 15

A -drugs therapeutically equivalent to pharmaceutical
equivalent products
B -drugs not therapeutically equivalent to
pharmaceutically equivalent products
AA -drugs not presenting bioequivalence problems
AB -Products meeting necessary bioequivalence
requirements

Front 16

Reasons for Dosage Form Development?

Back 16

To provide a safe and convenient delivery of accurate amount of a drug
•Additionally dosage forms are needed where:
–Drugs are susceptible to oxidation and hydration (e.g. coated tablets, sealed ampuls)
–Drugs are acid-labile, i.e. unstable at low pH in the stomach after oral administration (e.g. coated tablets)
–Drugs posses bitter, salty, or offensive taste or odor (e.g. capsules, coated tablets, flavored syrups)
–Placement of drugs directly into the bloodstream is needed (e.g. IV)

Front 17

Disciplines In Early Development

Back 17

Medicinal Chemistry
•Pharmaceutics
•Biopharmaceutics
•Pharmacokinetics
•Clinical/Medical

Front 18

Factors That Influence Bioavailability

Back 18

Physiological factors and patient characteristics
•Drug substance physicochemical properties
•Pharmaceutical ingredients and dosage form characteristics

Front 19

Factors that affect drug dissolution

Back 19

Crystal and amorphous
Surface area
Salt forms
sTATE of hydration

Front 20

different physiologyica GI TRACTS

Back 20

DURRRRRRRRRRRR