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Drugs

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Pharm / Tox

 Title and Format  Type  Issue Date
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule Draft 1/16/2009
Carcinogenicity Study Protocol Submissions Final 5/22/2002
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products Final 10/2000
Developing Medical Imaging Drug and Biological Products Final 6/17/2004
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers Final 7/21/2005
Exploratory IND Studies Final 1/12/2006
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* Final 2/1987
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches Draft 12/15/2008
Immunotoxicology Evaluation of Investigational New Drugs Final 10/2002
Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (Issued , Posted 11/9/2001) Draft 11/2001
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals   Draft 6/17/2005
Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives Final 10/96
Updated
7/2005
Nonclinical Safety Evaluation of Drug or Biologic Combinations   Final 3/14/2006
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route Draft 3/7/2008
Nonclinical Safety Evaluation of Pediatric Drug Products   Final 2/14/2006
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients Final 05/18/2005
Photosafety Testing Final 5/7/2003
Recommended Approaches to Integration of Genetic Toxicology Study Results   Final 1/3/2006
Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies Final 3/2/1998
Safety Testing of Drug Metabolites
Final

2/14/2008
Single Dose Acute Toxicity Testing for Pharmaceuticals  Final 8/1996
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals   Draft 5/2001
    
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