Literature DB >> 25190270

Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team.

R J Briggs1, R Nicholson, F Vazvaei, J Busch, M Mabuchi, K S Mahesh, M Brudny-Kloeppel, N Weng, P A R Galvinas, P Duchene, Pei Hu, R W Abbott.   

Abstract

This paper presents the recommendations of the Global Bioanalytical Consortium Harmonization Team on method transfer, partial validation, and cross validation. These aspects of bioanalytical method validation, while important, have received little detailed attention in recent years. The team has attempted to define, separate, and describe these related activities, and present practical guidance in how to apply these techniques.

Mesh:

Year:  2014        PMID: 25190270      PMCID: PMC4389741          DOI: 10.1208/s12248-014-9650-3

Source DB:  PubMed          Journal:  AAPS J        ISSN: 1550-7416            Impact factor:   4.009


  8 in total

1.  Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

Authors:  Binodh DeSilva; Wendell Smith; Russell Weiner; Marian Kelley; JoMarie Smolec; Ben Lee; Masood Khan; Richard Tacey; Howard Hill; Abbie Celniker
Journal:  Pharm Res       Date:  2003-11       Impact factor: 4.200

2.  Anticoagulant counter ion impact on bioanalytical LC-MS/MS assay performance: additional validation required?

Authors:  Carl Johan Sennbro; Magnus Knutsson; Philip Timmerman; Peter van Amsterdam
Journal:  Bioanalysis       Date:  2011-11       Impact factor: 2.681

3.  Request for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis.

Authors:  Philip Timmerman; Steve Lowes; Douglas M Fast; Fabio Garofolo
Journal:  Bioanalysis       Date:  2010-04       Impact factor: 2.681

4.  Towards harmonized regulations for bioanalysis: moving forward!

Authors:  Peter van Amsterdam; Berthold Lausecker; Silke Luedtke; Philip Timmerman; Margarete Brudny-Kloeppel
Journal:  Bioanalysis       Date:  2010-04       Impact factor: 2.681

5.  Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation.

Authors:  Peter van Amsterdam; Mark Arnold; Surendra Bansal; Douglas Fast; Fabio Garofolo; Steve Lowes; Philip Timmerman; Eric Woolf
Journal:  Bioanalysis       Date:  2010-11       Impact factor: 2.681

Review 6.  Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations.

Authors:  Douglas M Fast; Marian Kelley; C T Viswanathan; Jacqueline O'Shaughnessy; S Peter King; Ajai Chaudhary; Russell Weiner; Anthony J DeStefano; Daniel Tang
Journal:  AAPS J       Date:  2009-04-21       Impact factor: 4.009

7.  Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Authors:  Steve Lowes; Mark Boterman; Mira Doig; Massimo Breda; Jim Jersey; Richard Lelacheur; Ronald Shoup; Fabio Garofolo; Isabelle Dumont; Suzanne Martinez; Shane Needham; Jennifer Zimmer; Maria Cruz Caturla; Philippe Couerbe; John Maltas; Ray Steffen; James Petrilla; Afshin Safavi; Kayode Awaiye; Masood Bhatti; Curtis Sheldon; Christine Schiebl; Petra Struwe; Douglas Turk; Timothy Sangster; Colin Pattison; Douglas Fast; Lee Goodwin; John Kamerud; Andrew Dinan; Dan Mamelak; Rafiq Islam; Rudi Segers; Zhongping John Lin; Jim Hillier; Wei Garofolo; Lois Folguera; Dieter Zimmer; Thomas Zimmermann; Maria Pawula; Marc Moussallie; Leonardo de Souza Teixeira; Thais Rocha; John Allinson; Paula Jardieu; Daniel Tang; Dominique Gouty; Laura Wright; James Truog; Jenny Lin; Yasuhiro Yamashita; Masood Khan; Yansheng Liu; Allan Xu; Richard Lundberg; Chris Cox; Alan Breau; Roger Hayes; Chiara Bigogno; Dick Schoutsen; Carmen Dilger; Jianine Jonker; Mohammed Bouhajib; Ann Levesque; Sofi Gagnon-Carignan; Jake Harman; Robert Nicholson; Rand Jenkins; Mark Warren; Ming Hung Lin; Shane Karnik; Theo De Boer; Richard Houghton; Rachel Green; William Demaio; Romuald Sable; Kirk Smith; Christoph Siethoff; Laura Cojocaru; Mike Allen; Scott Reuschel; Pilar Gonzalez; Tammy Harter; Saadya Fatmi; Marie Rock; Jenifer Vija; Farhad Sayyarpour; Michele Malone; William Nowatzke; Stuart Best; Xinping Fang
Journal:  Bioanalysis       Date:  2012-09       Impact factor: 2.681

8.  2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Authors:  Binodh DeSilva; Fabio Garofolo; Mario Rocci; Suzanne Martinez; Isabelle Dumont; France Landry; Catherine Dicaire; Gabriella Szekely-Klepser; Russell Weiner; Mark Arnold; Surendra Bansal; Kevin Bateman; Ronald Bauer; Brian Booth; Scott Davis; Sherri Dudal; Dominique Gouty; John Grundy; Sam Haidar; Roger Hayes; Mohammed Jemal; Surinder Kaur; Marian Kelley; Magnus Knutsson; Olivier Le Blaye; Jean Lee; Steve Lowes; Mark Ma; Toshinari Mitsuoka; João Tavares Neto; Robert Nicholson; Eric Ormsby; Jeffrey Sailstad; Lauren Stevenson; Daniel Tang; Jan Welink; C T Viswanathan; Laixin Wang; Eric Woolf; Eric Yang
Journal:  Bioanalysis       Date:  2012-09       Impact factor: 2.681

  8 in total
  4 in total

1.  Introduction to the proposals from the global bioanalysis consortium harmonization team.

Authors:  Philip Timmerman; Mark Arnold; Binodh DeSilva; Fabio Garofolo; Michaela Golob; Peter van Amsterdam; Shinobu Kudoh; Puran Singhal; Daniel Tang; Maria Francesca Riccio; Rafael Barrientos; Shrinivas Savale; Tatsuo Kurokawa
Journal:  AAPS J       Date:  2014-10-02       Impact factor: 4.009

Review 2.  Comparative Stability of Two Anti-hyperpigmentation Agents: Kojic Acid as a Natural Metabolite and Its Di-Palmitate Ester, Under Oxidative Stress; Application to Pharmaceutical Formulation Design.

Authors:  Sahar Tazesh; Elnaz Tamizi; Mohammadreza Siahi Shadbad; Nazli Mostaghimi; Farnaz Monajjemzadeh
Journal:  Adv Pharm Bull       Date:  2021-05-30

Review 3.  Vitamin D Metabolism and Profiling in Veterinary Species.

Authors:  Emma A Hurst; Natalie Z Homer; Richard J Mellanby
Journal:  Metabolites       Date:  2020-09-15

4.  Single-Ascending-Dose Pharmacokinetic Study of Tribendimidine in Opisthorchis viverrini-Infected Patients.

Authors:  Urs Duthaler; Somphou Sayasone; Fiona Vanobbergen; Melissa A Penny; Peter Odermatt; Jörg Huwyler; Jennifer Keiser
Journal:  Antimicrob Agents Chemother       Date:  2016-09-23       Impact factor: 5.191

  4 in total

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