Regulatory documents and Guidelines
Since 1989, Eurofins ADME BIOANALYSES has been successfully inspected by
- FDA, in 2009, 2017 and 2021 (Inspections on bioequivalence studies)
- ANSM,(French GLP authorities for pharmaceuticals and cosmetics), every two years
- COFRAC/GIPC (French GLP authorities for chemicals), every two years
- ANSES (French GLP authorities for veterinary drugs), every three years
Eurofins ADME BIOANALYSES designs drug development programmes in accordance with the latest updates in regulatory guidelines and works with diverse European agences to achieve this
REGULATORY DOCUMENTS
- OECD Good Laboratory Practice - ENV/MC/CHEM(98)17
- European Good Laboratory Practice – Directive 2004/10/EC
- French Good Laboratory Practice - Arrêté du 14 mars 2000, (For pharmaceutical products)
- French Good Laboratory Practice - Arrêté du 10 août 2004 (For cosmetics)
- French Good Laboratory Practice - Arrêté du 28 janvier 2005 (For veterinary drugs)
- French Good Laboratory Practice - Article annexe II à l’article D523-8 du code de l’environnement (For chemical products)
GUIDELINES
* For small molecule bioanalysis:
ICH-M10 guideline on bioanalytical method validation and study sample analysis adopted by EMA in Jul 2022 and FDA in Nov 2022
EMA, Guideline on the investigation of bioequivalence - August 2010
FDA, Guidances for Industry for Bioavailability / Bioequivalence Studies - 2019
EMA, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples - February 2012
VICH GL1 - Guideline on validation of analytical procedures: definition and terminology
VICH GL2 - Guideline on validation of analytical procedures: methodology
VICH GL49 - VALIDATION OF ANALYTICAL METHODS USED IN RESIDUE DEPLETION STUDIES
* For immunoassays and immunogenicity:
FDA, Guideline for Industry Bioanalytical Method Validation - May 2018
FDA, Guidance for Industry: Immunogenicity Testing of Therapeutic Proteins products - Developing and Validating Assays for Anti-Drug Antibody Detection - January 2019
EMA, Guideline on bioanalytical method validation - July 2011
EMA, Guideline on immunogenicity assessment of therapeutic proteins - May 2017
EMA, Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use - May 2012
EMA, Guideline on the investigation of bioequivalence - August 2010
FDA, Guidances for Industry for Bioavailability / Bioequivalence Studies
EMA, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples - February 2012
*For biomarkers:
Biomarker qualification: evidentiary framework, Guidance for industry and FDA, Dec 2018
* For percutaneous penetration and dermal exposure risk assessment of topical formulations:
OECD N°428 Guideline for the testing of chemicals: Skin absorption, in vitro method - April 2004
OECD N°427 Guideline for the testing of chemicals guideline: Skin absorption, in vivo method - April 2004
OECD N°156 Guidance notes on dermal absorption - August 2011
OECD N°28 Guidance document for the conduct of skin absorption studies - March 2004
SCCS Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients - SCCS/1358/10 - June 2010
EFSA Guidance on dermal absorption 2017; 15(6):4873
ECHA Guidance on the Biocidal Product Regulation Volume III Human Health - Assesment & Evaluation (parts B+C) Version 4.0 December 2017
* For equivalence assessment of topical drug products:
EMA Draft guideline on quality and equivalence of topical products – October 2018
FDA Draft - In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs – October 2022
FDA Draft - In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs - October 2022
* For in vivo studies:
Animal Health Regulations European Guidance 2010/63/UE
* For transdermal patches:
EMA Guideline on quality of transdermal patches - EMA/CHMP/QWP/608924/2014 - 23 October 2014
FDA Draft - Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry - November 2019
* Transdermal and Topical Delivery Systems - Product Development and Quality Considerations Guidance for Industry:
DRAFT GUIDANCE November 2019
