PCOL 355 Exam 1 Questions with Correct Answers

PCOL 355 Exam 1 Questions with Correct Answers What is the word for materials added to a drug formulary to help maintain the stability of the drug? - Answer-Excipients (ex: plasticizes) Name the 5 forms of injection drugs and their corresponding depth. - Answer-1. Intramuscular (IM)- muscle 2. Subcutaneous (SQ)- subcutaneous 3. Intravenous (IV)- dermis 4. Intradermal (ID)- epidermis 5. Microneedles- dermis+epidermis Describe the pathway of drug development from drug discovery to the market? (total time is 10-15 years) - Answer-Discovery & Preclinical: 3-6 years 1. Discovery: 5,000-10,000 compounds 2. Preclinical: 250 compounds tested in-vivo (animals) and in-vitro (test tubes) 3. Submission of INDA Clinical Trials: 6-7 years 4. Phase I: 20-100 healthy volunteers (tolerance) 5. Phase II: 100- 500 volunteers with the disease (efficacy) 6. Phase III: 1,000-5,000 patients with the disease across institutions (tolerance and efficacy) Submission of NDA: FDA Review (0.5-2 years) 7. Phase IV: Drug approval, post market surveillance Identify 2 reasons for a compound to fail or slow down during development. - Answer-Fail: 1. poor biopharmaceutial properties 2. lacks efficacy 3. toxicities 4. market reasons Slow down: 1. synthetic complexity 2. ambiguous toxicity 3. poor biopharmaceutial properties 4. low potency