Food and Drug Administration Guidance for Industry

FDA. Food and Drug Administration. Guidance for Industry, Pharmacoge-nomic Data Submissions. March 2005. 

Food and Drug Administration Guidance for Industry. Extended Release Oral Dosage Forms Development, Evaluation, and Application of In Vitro/In Vivo Correlations, September 1997. 

Food and Drug Administration Guidance for Industry. SUPAC-MR Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, October 1997. 

Food and Drug Administration. Guidance for Industry, Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product, FDA, Rockville, MD, 1999. 

Source Food and Drug Administration. Guidance for Industry— Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. http //www.fda.gov/cber/gdlns/toxvac.htm [accessed September 28,2007]. 

U.S. Food and Drug Administration. Guidance for Industry Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPT) Drug Products (Draft). Center for Drug Products (Draft). Center for Drug Evaluation and Research (Oct. 1998). 

Food and Drug Administration. Guidance for Industry. 21 CFR Part 11. Electronic Records Electronic Signatures. Glossary of Terms—Draft Guidance. Washington, D. C., Aug. 2001. (Later withdrawn by the FDA.)... 

Food and drug administration. Guidance for industry Population pharmacokinetics, available at http //www.fda.gov/cder/guidance/1852fnl.pdf accessed November 10,... 

Food and Drug Administration. Guidance for Industry Exposure-Response Relationship, Study Design, Data Analysis, and Regulatory Applications, April 2003 (posted May 2003). Available at http //www.fda.gov/cder/. Accessed October 6, 2006. 

CPMP/ICH/281/95 (1996) EEC Note for Guidance, Validation of Analytical Procedures Methodology. London UK U.S. Department of Health and Human Services Food and Drug Administration, Guidance for Industry (2001) Bioanalytical Method Validation. U.S. Department of Health and Human Services Beltsville, MD USA... 

United States Food and Drug Administration Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Consideration, October 2000. 

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