Guidance & White Papers
The following guidance documents and white papers are available for download without charge or obligation:
Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies
Food and Drug Administration (2006)
Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase I Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
Bioanalysis
Draft Guideline on Validation of Bioanalytical Methods
Workshop Report and Follow-Up – AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples –Implications of Crystal City Recommendations
Workshop/Conference Report – Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
Recommendations for the Design and Optimization of Immunoassays used in the Detection of Host Antibodies Against Biotechnology Products
Journal of Immunological Methods (2004)
Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules
Pharmaceutical Research (2003)
Guidance for Industry: Bioanalytical Method Validation
Food and Drug Administration (2001)
Clinical Pharmacology
Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs – Improving Human Subject Protection
Food and Drug Administration (2009)
Guidance for Industry: Safety Testing of Drug Metabolites
Food and Drug Administration (2008)
Draft Guidance for Industry: Drug Interaction Studies – Study Design, Data Analysis, and Implications for Dosing and Labeling
Food and Drug Administration (2006)
Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
Food and Drug Administration (2005)
The Conduct of In Vitro and In Vivo Drug-Drug Interaction Studies: A Pharmaceutical Research and Manufacturers of America (PhRMA) Perspective
Drug Metabolism and Disposition (2003)
Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies
Food and Drug Administration (2002)
Guidance for Industry: Population Pharmacokinetics
Liposome Drug
Draft Guidance for Industry: Liposome Drug Products – Chemistry, Manufacturing and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
Translational Medicine
Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins
Food and Drug Administration (2009 Draft)
E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions
Food and Drug Administration (2009 Draft)
Recommendations on Risk-Based Strategies for Detection and Characterization of Antibodies against Biotechnology Products
Journal of Immunological Methods (2008)
Recommendations for the Validation of Immunoassays used for Detection of Host Antibodies against Biotechnology Products
Journal of Pharmaceutical and Biomedical Analysis (2008)
Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
Food and Drug Administration (2008)
Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement
Pharmaceutical Research (2006)
Guidance for Industry: Pharmacogenomic Data Submissions
Food and Drug Administration (2005)
