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Life Sciences
Researchers from Food & Drug Administration report recent findings in life sciences
July 9th, 2008
"The mission of the US Food and Drug Administration (FDA) is to protect public health by ensuring the safety, efficacy, and quality of drugs. In drug development, animal studies play a key role in assessing the safety (toxicology), pharmacokinetics (PK), and proof-of-concept efficacy of a new product," scientists writing in the journal Clinical Pharmacology & Therapeutics report. "When clinical studies are neither ethical nor feasible to conduct, the Animal Rule (67 FR 37988, 2002) introduces the potential for drug (e. g., countermeasure) approval based on efficacy studies in animals, and appropriate human safety and pharmacokinetic information. The Center for...
Source: Vaccine Weekly (2008-07-09)
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