Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
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Standards in Drug Development<br />
• GLP – Good Laboratory Practice<br />
• GCP – Good Clinical Practice<br />
• GMP or cGMP – (current) Good<br />
Manufacturing Practice<br />
• 21 CFR - Title 21 CFR Part 11 <strong>of</strong> the Code <strong>of</strong> Federal Regulations<br />
11%