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Questions and Answers
What is the primary goal of the research and early development stage in drug design?
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?
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?
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?
What is the primary purpose of chemical and pharmaceutical development in drug design?
What is the purpose of clinical research in drug design?
What is the purpose of clinical research in drug design?
What is the purpose of submitting the drug for regulatory approval in drug design?
What is the purpose of submitting the drug for regulatory approval in drug design?
What is the primary goal of Phase 0 in human testing on drugs?
What is the primary goal of Phase 0 in human testing on drugs?
What is the duration of a drug patent in the United States?
What is the duration of a drug patent in the United States?
Which agency is responsible for regulating the advertising of prescription drugs?
Which agency is responsible for regulating the advertising of prescription drugs?
What is the purpose of an escalation study in Phase 1 of human testing on drugs?
What is the purpose of an escalation study in Phase 1 of human testing on drugs?
What is the primary goal of Phase 3 in human testing on drugs?
What is the primary goal of Phase 3 in human testing on drugs?
What is the purpose of the first segment of the National Drug Code?
What is the purpose of the first segment of the National Drug Code?
What type of tablet is designed to dissolve in the alkaline environment of the small intestine?
What type of tablet is designed to dissolve in the alkaline environment of the small intestine?
What is the purpose of Phase 4 in human testing on drugs?
What is the purpose of Phase 4 in human testing on drugs?
What is the primary function of microsomal enzymes in drug metabolism?
What is the primary function of microsomal enzymes in drug metabolism?
What is the characteristic of prodrugs?
What is the characteristic of prodrugs?
What is the result of enzyme inhibition?
What is the result of enzyme inhibition?
What is the formula for drug clearance?
What is the formula for drug clearance?
What is the characteristic of non-microsomal enzymes?
What is the characteristic of non-microsomal enzymes?
What is the purpose of phase 2 reactions?
What is the purpose of phase 2 reactions?
What is the effect of repeated drug administration on microsomal enzymes?
What is the effect of repeated drug administration on microsomal enzymes?
What is the characteristic of drugs that can go to phase 2 without going through phase 1?
What is the characteristic of drugs that can go to phase 2 without going through phase 1?
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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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