Drug Development

Question 1

What is Stage 1 in the drug development cycle and describe it.

Answer 1

Stage 1: Discovery Phase
Chemical modifications of new drugs, screening of natural products for activity, rational drug design based on know molecular mechanisms

Question 2

What is Stage 2 in the drug development cycle and describe it.

Answer 2

Stage 2: Preclinical Investigation: Safety and Toxicity Testing
Always done in animals (rodents) then data extrapolated to humans; range 1-3 years; investigates acute, subacute and chronic toxicity, reproductive function effects, carcinogenicity. mutagenicitiy, teratogenicity.

Question 3

What is Stage 3 in the drug development cycle and describe it.

Answer 3

IND - Notice of Claim Investigational Exemption for New Drug (3 Phases)

Question 4

What is Stage 4 in the drug development cycle and describe it.

Answer 4

NDA - New Drug Application

Question 5

What is Stage 5 in the drug development cycle and describe it.

Answer 5

Phase 4 Approval for marketing and safety monitoring under actual usage

Question 6

What is a Notice of Claim Investigational Exemption for New Drug (IND)?

Answer 6

Involves 3 phases of clinical trials that require informed consent including approvals from FDA and organization sponsoring IND and institutional IRB of trial site; new drug application (NDA) that reports on preclinical and clinical data with FDA review; approval for marketing and post marketing surveillance

Question 7

What is Phase I of clinical trials?

Answer 7

Phase 1 - Investigation Exemption for New Drug.
Healthy volunteers; major goals to establish dose range limits; observe for safety of tested doses; prelminary pharmacokinetic data.

Question 8

What is Phase 2 of clinical trials?

Answer 8

Phase 2 - Investigation Exemption for New Drug. Tests in patients with disease states; safety and efficacy are examined

Question 9

What is Phase 3 of clinical trials?

Answer 9

Phase 3 - Investigation Exemption for New Drug
Evaluation in much larger numbers of patients; multicenter trials; employs actual use conditions with route and dosing schedule; efficacy and broader range toxicity explored

Question 10

What is Investigation Exemption for New Drug - New Drug Application (NDA)

Answer 10

Full reports of all preclinical and clinical data; FDA review.

Question 11

What is Phase 4 of clinical trials?

Answer 11

Phase 4 Approval for marketing and safety monitoring under actual usage