Paper Review Records
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15 valid samples · Newest publication first
Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars
AuthorsAnita Krishnan; Somesh BP; Gaurav Mehta; Shilpa Ramaswamy; Soumen Chakraborty; Shyamapada Mandal
Affiliations1. Biocon Biologics
From analytical similarity to clinical confidence: how regulatory evolution ensures comparable immunogenicity in streamlined biosimilar development
AuthorsSandra Ribes; Marc Rosenbaum; Laura Hartmann; Lisa Allmannsberger; Johann Poetzl
Affiliations1. Hexal AG (a Sandoz company)
A validated bioanalytical LC-MS/MS method for the simultaneous determination of molnupiravir, N-hydroxycytidine, and baricitinib in human plasma
AuthorsFatma H. Ghazy; Ramzia I. El-Bagary; Samar H. Fahim; Sally T. Mahmoud
Affiliations1. Cairo University; 2. School of Pharmacy, New Giza
Electrochemiluminescence immunoassay for quantifying ZMA001 in human serum: method development, validation, and clinical pharmacokinetic application
AuthorsAbdul-Azeez A. Lanihun; Oluwatobi T. Arisa; Olivia Poczatek; Yi Zeng; Nam Hoon Kwon; Sunghoon Kim; Sandra Cooper; Jason M. Elinoff; William D. Figg
Affiliations1. Clinical Pharmacology Laboratory, Clinical Center, National Institutes of Health, Bethesda, MD, USA; 2. Department of Pharmaceutical Sciences, College of Pharmacy, Howard University, Washington, DC, USA; 3. Research Institute, Zymedi Co., Ltd., Incheon, South Korea; 4. Department of Integrative Biotechnology, Interdisciplinary Graduate Program, Yonsei University, Incheon, South Korea; 5. Critical Care Medicine and Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA; 6. Critical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD, USA; 7. Clinical Pharmacology Program, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA
Highlights from the 17th Japan Bioanalysis Forum Symposium
AuthorsKatsutomo Hata; Naohito Yamada; Hiroyuki Shimizu; Tomoko Arakawa; Hitoshi Uchiyama; Miyuki Ugajin; Takeshi Okuzono; Eiichi Shimada; Masanori Nagata; Masayo Hashimoto; Hisanori Hara; Takashi Miyayama; Tamiki Mori; Ken-Ichi Yamamoto
Affiliations1. Shionogi & Co., Ltd; 2. Tanabe Pharma Corporation; 3. Pfizer R&D Japan G.K; 4. Towa Pharmaceutical Co., Ltd; 5. Takeda Pharmaceutical Co., Ltd; 6. Sekisui Medical Co., Ltd; 7. Ono Pharmaceutical Co., Ltd; 8. Astellas Pharma Inc; 9. Otsuka Pharmaceutical Co., Ltd; 10. B2S Life Sciences LLC; 11. Chugai Pharmaceutical Co., Ltd; 12. Mediford Corporation; 13. Shin Nippon Biomedical Laboratories, Ltd
Investigating the relationship between relative accuracy and linearity acceptance criteria in bioassay validation for clinical studies
AuthorsPietro Piu; Stefano Auddino; Gioele Bernardoni; Emanuele Montomoli; Alessandro Manenti
Affiliations1. VisMederi S.r.l; 2. University of Siena
Development of an electrochemiluminescence-based bridging assay to detect antibodies against a PTH inverse agonist in human plasma
AuthorsAsvelt J. Nduwumwami; Erik J. Wagner; Amy Q. Wang; Yuhong Fang; Dingyin Tao; Xin Xu
Affiliations1. National Institutes of Health
Development and validation of a LC-MS/MS method for the quantification of the E-type prostanoid receptor 4 antagonist HTL0039732 in human plasma, for a Phase I/IIa clinical trial
AuthorsDan Astley; Svatopluk Svetlik; Shelby Barnett; Gareth J. Veal
Affiliations1. Newcastle University Centre for Cancer, Newcastle University; 2. Cancer Research UK Centre for Drug Development
Development and validation of a sensitive HPLC-MS/MS method for the analysis of semaglutide in human plasma
AuthorsChristopher Tudan; Joel Stickling; Emily Northwick Darden; Lauren Devine; Shane Needham
Affiliations1. Veloxity Labs, LLC
Comparison of TISAB II and III for salivary fluoride determination: addressing a bioanalytical challenge in fluoride analysis
AuthorsFlavia Almeida Amorim; Maria Suzi de Sousa Lopes; Lyzia Vitoria Mendes Rezende; Evanildo Canuto Paz; Marcus Vinícius Oliveira; Glauber Campos Vale
Affiliations1. Federal University of Piaui
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