New Drug Development: A Regulatory Overview |
Contents
An Introduction to the U S New Drug Approval Process | 1 |
Nonclinical Drug Testing | 17 |
The FDAs Regulation of Nonclinical Testing Good Laboratory Practice GLP | 39 |
Copyright | |
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Common terms and phrases
adverse experience advisory committee agency agency's amendments animal approved drug assessment bioavailability carcinogenicity CDER CDER's CGMP changes chemistry clinical development Clinical Evaluation clinical hold clinical investigation clinical studies clinical testing clinical trials conducted Content copy designed discussion disease document dosage form dose draft guideline Drug and Biological Drug Applications drug approval drug development Drug Products drug review divisions drug sponsors drug substance Drug User Fee drug's FDA regulations FDA's federal regulations guidance human IND submission informed consent initial inspections Institutional Review Board investigational drug investigational product investigator's brochure issues labeling laboratory life-threatening manufacturing meeting monitoring NDA review NDA's nonclinical studies Office orphan drug patients pharmaceutical Pharmacokinetics pharmacology Phase 1 studies preclinical procedures proposed protocol regulatory relevant requirements response review process safety and effectiveness SNDA specific standards subjects submitted summary surrogate endpoints therapeutic therapy tion toxicity studies treatment IND