Check Yourself — Lesson 1

Answers to Exercise 1-C

DEVELOPMENT PHASE DESCRIPTIONS

6. Phase III Clinical Trial	Studies to determine the long term adverse effects in 1,000-3,000 volunteers with the targeted disease.
2. Biological Testing	Initial screening for potential activity, toxicity, and stability.
4. Phase I Clinical Trial	Studies on 20-80 healthy volunteers to determine safe dosage ranges, absorption, and metabolism.
8. Post Marketing	Reports to the FDA of any adverse reactions or quality control issues. The FDA may also require Phase IV studies. Possible patent extensions, product recalls or withdrawal from market.
5. Phase II Clinical Trial	Studies to evaluate efficacy and adverse effects in 100-300 volunteers with the targeted disease.
1. Discovery	Synthesis, isolation, chemical and physical characterization.
7. Approval	FDA approves a drug for marketing for interstate sales for specific dosage forms and indications.
3. Pre-clincal/Animal Testing	Extensive series of laboratory and animal studies to evaluate safety and biological activity against the targeted disease.

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If you answered 6 or more correctly, congratulations!

If you got less than 6 correct, review the section in Lesson 1 on Drug R&D Process Overview.

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