General Biotechnology

Question 1

Food and Drug Administration (FDA) Oversees ______________________________

Answer 1

Drug Approval/Clinical Trials

Question 2

An Institutional Review Board (IRB) consisting of __________________________ oversees ____________________

Answer 2

scientists, lay persons, and other professionals

clinical trial approval and progress

Question 3

Dept. of Agriculture has oversight over

Answer 3

environmental related products

Question 4

cG(L,M,C)P =

Answer 4

Current Good (Laboratory, Manufacturing, Clinical) Practices

Lab from Early Research to End, Manufacturing and Clinical Self-Explanatory

Question 5

R&D

Answer 5

focuses on developing new and better materials, new protocols, enhanced efficiency

Question 6

Manufacturing

Answer 6

creates the actual product and records batch information

Question 7

QC (quality control)

Answer 7

ensures products and materials are what is claimed, checks purity and concentration, etc.

Question 8

QA (quality assurance) oversees

Answer 8

documents, stores, and distributes all protocols and has final approval based on QC reports

Question 9

Phase 1 Clinical trial

Answer 9

Dosage, Side Effects, General Safety

Question 10

Phase 2 clinical trial

Answer 10

Effectiveness in Target Group

Question 11

Phase 3 clinical trial

Answer 11

Scaled Up - Larger # of Participants