Listing of and reference to guidance documents and regulations of national governmental and international and non-governmental organizations relevant for the conduct of regulated bioanalysis. Relevant conference and opinion papers are listed on: Publications / Other and those from the EBF are on: Publications / EBF Publications
Analytical Method Validation
Bioanalytical Method Validation (BMV)
- ANVISA - Guide For Validation Of Analytical And Bioanalytical Methods
- EMA - Guideline on Validation of Bioanalytical Methods
- FDA - Guidance for Industry: Bioanalytical Method Validation
Bioavailability and Bioequivalence (BA & BE)
- ANVISA - Manual for Good Bioavailability and Bioequivalence Practices. Volume 1
- ANVISA - Manual for Good Bioavailability and Bioequivalence Practices. Volume 2
- EMEA - Guideline on the Investigation of Bioequivalence
- FDA - 21 CFR Part 320, Bioavailability and bioequivalence requirements
Biopharmaceuticals
- EMEA - Concept paper for Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use
- EMEA - Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins
- ICH - S8: Immunotoxicity Studies for Human Pharmaceuticals
Computer System Validation (CSV)
- FDA - 21 CFR Part 11, Electronic Records; Electronic Signatures -Scope and Application
- FDA - Guidance for Industry - Computerized Systems Used in Clinical Investigations
Good Clinical Practice (GCP)
- ICH - E6(R1): Guideline for Good Clinical Practice
- EU - EU Directive 2001/20/EC Clinical trial directive
- EU - EU Directive 2005/58/EC Clinical trial directive
- MHRA - Good Clinical Practice - Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples.
Good Clinical Laboratory Practice (GCLP)
- BARQA - Good Clinical Laboratory Practice (GCLP)
- EMA - Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples
- WHO - Good Clinical Laboratory Practice (GCLP)
Good Laboratory Practice (GLP)
- FDA - 21CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
- OECD - Principles of Good Laboratory Practice and Compliance Monitoring
- No 1: OECD Principles on Good Laboratory Practice
- No 4: Quality Assurance and GLP
- No 5: Compliance of Laboratory Suppliers with GLP Principles
- No 7: The Application of the GLP Principles to Short&Term Studies
- No 8: The Role and Responsibilties of the Study Director in GLP Studies
- No 10: The Application of the Principles of GLP to Computerised Systems
- No 11: The Role and Responsibility of the Sponsor in the Application of the Principles of GLP
- No 13: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies
- No 14: The Application of the Principles of GLP to in vitro Studies
- No. 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
Immunogenicity
see also Biopharmaceuticals
- EMEA - Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
- FDA - Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins (draft 03-dec-2009)
Metabolites In Safety Testing (MIST)
- ICH - M3(R2): Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- FDA - Guidance for Industry - Safety Testing of Drug Metabolites
Toxicokinetcs (TK)
- EMEA - Evaluation of Control Samples for Non - clinical Safety Studies: Checking for Contamination with the Test Substance
- ICH - S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
Toxicology
- EMEA - Non-Clinical Safety Studies For The Conduct Of Human Clinical Trials For Pharmaceuticals (ICH M3[R2]) modification
- ICH - M3(R2): Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- FDA - S7A Safety Pharmacology Studies for Human Pharmaceuticals
Last update: 13-Sep-2011
