A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs-Reference-Cited by-同舟云学术

A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs

Published:2020-10-28 Issue:6 Volume:3 Page:1310-1317
ISSN:2575-9108
Container-title:ACS Pharmacology & Translational Science
language:en
Short-container-title:ACS Pharmacol. Transl. Sci.

Author:

Yang Kun¹^ORCID,Zhang Ying²,Chou Robert²,Yeung Lai¹,Letarte Simon³,Yang Rong-Sheng³,Li Xuanwen³,Beaumont Maribel⁴,Gunawan Rico²,Richardson Douglas³,Dellatore Shara¹,Woolf Eric⁵,Xu Yang⁵

Affiliation:

1. Regulated Bioanalysis, Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, New Jersey 07033, United States

2. Biologics Analytical Research & Development, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, New Jersey 07033, United States

3. Analytical Research & Development Mass Spectrometry, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, New Jersey 07033, United States

4. Discovery Bioanalysis, Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co., Inc., 213 E Grand Avenue, South San Francisco, California 94080, United States

5. Regulated Bioanalysis, Pharmacokinetics, Pharmacodynamics & Drug Metabolism, Merck & Co., Inc., 770 Sumneytown Pike, WP75B-300, West Point, Pennsylvania 19486, United States

Publisher

American Chemical Society (ACS)

Subject

Pharmacology (medical),Pharmacology

Link

https://pubs.acs.org/doi/pdf/10.1021/acsptsci.0c00135

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