2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop-Reference-Cited by-同舟云学术

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

Published:2010-01 Issue:1 Volume:2 Page:53-68
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Savoie Natasha¹,Garofolo Fabio¹,van Amsterdam Peter²,Booth Brian P³,Fast Douglas M⁴,Lindsay Michael⁵,Lowes Steve⁶,Masse Robert⁷,Mawer Louise⁸,Ormsby Eric⁹,Phull Rupinder¹⁰,Rocci Mario L¹¹,Vallano Patrick T¹²,Yin Xia⁵

Affiliation:

1. Algorithme Pharma Inc., 575 Armand-Frappier Blvd, Laval (Montreal) QC, H7V 4B3, Canada.

2. Solvay Pharmaceuticals, Weesp, The Netherlands

3. Food and Drug Administration, CDER, Silver Spring, MD, USA

4. Pfizer Global Research and Development, Groton, CT, USA

5. Apotex Inc., Weston, ON, Canada

6. Advion BioServices Inc., Ithaca, NY, USA

7. Anapharm Inc., Quebec City, QC, Canada

8. Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK

9. Health Canada TPD, Ottawa, ON, Canada

10. Barr Pharmaceuticals Inc., Montvale, NJ, USA

11. Prevalere Life Sciences Inc., Whitesboro, NY, USA

12. Mylan Pharmaceuticals Inc., Morgantown, WV, USA

Abstract

The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several ‘hot’ topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.09.134

Reference18 articles.

1. Society Spotlight: Spotlight on the Calibration and Validation Group

2. The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

3. Health Products and Food Branch. Guidance for industry: conduct and analysis of bioavailability and bioequivalence studies – part A and part B. Health Products and Food Branch, ON, Canada (1992).

4. Health Products and Food Branch. Draft guidance for industry: submission requirements for subsequent market entry inhaled corticosteroid products for use in the treatment of asthma. Health Products and Food Branch, ON, Canada (2007).

5. US Food and Drug Administration.Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, MD, USA (2001).

Cited by 79 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. 2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine);Bioanalysis;2024-05-02

2. 2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies);Bioanalysis;2024-04-17

3. 2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization);Bioanalysis;2024-02-22

4. 2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization;Bioanalysis;2023-08

5. 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine);Bioanalysis;2023-08