Ding Lu
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Ding Lu has a total of 15 co-authors. Here are the top co-authors by number of shared publications:
- Andrea A. Romeo
Roche Pharma Research and Early Development Basel Switzerland
1 shared publication - Daniela Fraier
Pharmaceutical Sciences F. Hoffmann‐La Roche Ltd Basel Switzerland
1 shared publication - David S. Wagner
AbbVie Inc. North Chicago Illinois USA
1 shared publication - Douglas K. Spracklin
Pharmacokinetics, Dynamics, and Metabolism Pfizer Inc. Groton Connecticut USA
1 shared publication - Faye Vazvaei-Smith
Merck
1 shared publication - Filip Cuyckens
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium
1 shared publication
Latest Publications
- 12 March 2024
- Published by Wiley in Clinical Pharmacology & Therapeutics
- Vol. 115 (5) , 939-953
Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group
The intent of this perspective is to share the recommendations of the International Consortium for Innovation and Quality in Pharmaceutical Development Metabolite Bioanalysis Working Group on the fit‐for‐purpose metabolite bioanalysis in support of drug development and registration. This report summarizes the considerations for the trigger, timing, and rigor of bioanalysis in the various assessments to address unique challenges due to metabolites, with respect to efficacy and safety, which may arise during drug development from investigational new drug (IND) enabling studies, and phase I, phase II, and phase III clinical trials to regulatory submission. The recommended approaches ensure that important drug metabolites are identified in a timely manner and properly characterized for efficient drug development.
- 12 March 2024
- Published by Wiley in Clinical Pharmacology & Therapeutics
- Vol. 115 (5) , 939-953
Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group
The intent of this perspective is to share the recommendations of the International Consortium for Innovation and Quality in Pharmaceutical Development Metabolite Bioanalysis Working Group on the fit‐for‐purpose metabolite bioanalysis in support of drug development and registration. This report summarizes the considerations for the trigger, timing, and rigor of bioanalysis in the various assessments to address unique challenges due to metabolites, with respect to efficacy and safety, which may arise during drug development from investigational new drug (IND) enabling studies, and phase I, phase II, and phase III clinical trials to regulatory submission. The recommended approaches ensure that important drug metabolites are identified in a timely manner and properly characterized for efficient drug development.