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Objectives • New drug approval process • Pricing of new drugs • Off ...

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3/15/13%<br />

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%

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