Pharmaceuticals Regulation and Manufacturing

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Questions and Answers

What is the primary goal of the research and early development stage in drug design?

Collecting data from the new drug

Designing a product that is safe and efficient enough

Determining how good the product will be against the disease

Finding the cause of the disease and understanding its mechanism (correct)

What is the primary purpose of preclinical research in drug design?

Determining how good the product will be against the disease (correct)

Collecting data from the new drug

Designing a product that is safe and efficient enough

Submitting the drug for regulatory approval

What is the final stage of drug design before the drug is released to the market?

Chemical and pharmaceutical production (correct)

Clinical research

Research and early development

Preclinical research

What is the primary purpose of chemical and pharmaceutical development in drug design?

Designing a product that is safe and efficient enough Signup and view all the answers

What is the purpose of clinical research in drug design?

Collecting data from the new drug Signup and view all the answers

What is the purpose of submitting the drug for regulatory approval in drug design?

Obtaining permission to market the drug Signup and view all the answers

What is the primary goal of Phase 0 in human testing on drugs?

To find out how the drug behaves in the body and how abnormal cells react Signup and view all the answers

What is the duration of a drug patent in the United States?

17 years Signup and view all the answers

Which agency is responsible for regulating the advertising of prescription drugs?

Food and Drug Administration (FDA) Signup and view all the answers

What is the purpose of an escalation study in Phase 1 of human testing on drugs?

To find out how much of the drug is safe to give Signup and view all the answers

What is the primary goal of Phase 3 in human testing on drugs?

To compare the drug with existing treatments Signup and view all the answers

What is the purpose of the first segment of the National Drug Code?

To identify the drug company assigned by the FDA Signup and view all the answers

What type of tablet is designed to dissolve in the alkaline environment of the small intestine?

Enteric coated tablet Signup and view all the answers

What is the purpose of Phase 4 in human testing on drugs?

To find out the long-term risks and benefits of the drug Signup and view all the answers

What is the primary function of microsomal enzymes in drug metabolism?

To catalyze the oxidation, reduction, and hydrolysis of lipid soluble drugs Signup and view all the answers

What is the characteristic of prodrugs?

They need conversion to become active Signup and view all the answers

What is the result of enzyme inhibition?

Decreased metabolism of drugs Signup and view all the answers

What is the formula for drug clearance?

CL = rate of elimination/plasma conc. Signup and view all the answers

What is the characteristic of non-microsomal enzymes?

They are not inducible Signup and view all the answers

What is the purpose of phase 2 reactions?

To attach endogenous substrates to functional groups on drugs Signup and view all the answers

What is the effect of repeated drug administration on microsomal enzymes?

It induces the growth of the smooth ER, leading to enhanced microsomal enzyme activity Signup and view all the answers

What is the characteristic of drugs that can go to phase 2 without going through phase 1?

They have a functional group that can be attached to an endogenous substrate Signup and view all the answers

Study Notes

Drug Development and Regulation

Once approved by FDA, manufacturing of a drug can start
Isomers: 2 different compounds with the same formula but different arrangements of atoms
FDA regulates advertising of prescription drugs, while OTC drugs are regulated by Federal Trade Commission (FTC)

Drug Patents and Coding

Drug patents last for 17 years
National Drug Code consists of three segments: company code, drug strength/dose, and package size/type

Phases of Human Testing on Drugs

Phase 0: Test drug behavior in a small number of people, examining how drug behaves in the body and reacts with abnormal cells
Phase 1: Determine safe dosage, side effects, and body's response to the drug (escalation study)
Phase 2: Identify which cancer the treatment works for, and determine best dose and side effects (up to 100 people, placebo testing)
Phase 3: Compare drug with existing treatments, different doses, and standard treatment
Phase 4: Long-term risks and benefits after licensing

Dosage Forms

Solid dosage forms: tablets (uncoated, film-coated, sugar-coated, enteric-coated, sustained release), scored tablets, effervescent tablets
Schedule 4: moderate physical or psychological effects
Schedule 5: limited abuse and accepted medically

Drug Legislation and Agencies

Federal government: protects and regulates the industry
State government: practices acts and rules, dispensing and administration
Federal Food and Drug Act (1906): quality standards, proper labeling
Federal Food, Drug, Cosmetic Act (1938): drug effectiveness, animal testing, FDA approval
Durham-Humphrey Amendments (1952): OTC established

Drug Design and Development

Drug design: research and early development, preclinical research, chemical and pharmaceutical development, clinical research, production
Phase 1 metabolism: microsomal enzymes, hydrolysis, oxidation, reduction, decyclization
Phase 2 metabolism: attachment of endogenous substrate, polar and water-soluble, inactive metabolites

Enzymes and Metabolism

Microsomal enzymes: located in liver, intestinal mucosa, lungs, and kidney, catalyze oxidation, reduction, and hydrolysis
Non-microsomal enzymes: in cytoplasm, mitochondria, and plasma, catalyze phase 2 reactions
Prodrugs: inactive drugs converted to active forms, stable, more soluble, better bioavailability, fewer adverse effects
Enzyme induction: repeated administration induces growth of smooth ER, enhancing microsomal enzyme activity
Enzyme inhibition: drugs can inhibit metabolism, leading to toxicity

Drug Excretion and Clearance

Clearance: volume of plasma cleared of drug in unit time, CL = rate of elimination/plasma concentration

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Description

Learn about the process of manufacturing drugs after FDA approval, isomers, drug marketing, patents, and the national drug code. Understand the phases of human testing on drugs.