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Tytuł pozycji:

The use of emerging safety biomarkers in nonclinical and clinical safety assessment - The current and future state: An IQ DruSafe industry survey.

Tytuł :
The use of emerging safety biomarkers in nonclinical and clinical safety assessment - The current and future state: An IQ DruSafe industry survey.
Autorzy :
Zabka TS; Genentech Inc, 1 DNA Way, South San Francisco, CA, USA. Electronic address: .
Burkhardt J; Pfizer, 1 Eastern Point Road, Groton, CT, USA. Electronic address: .
Reagan WJ; Pfizer, 1 Eastern Point Road, Groton, CT, USA. Electronic address: .
Gautier JC; Sanofi, 13, Quai Jules Guesde, Vitry-sur-Seine, France. Electronic address: .
Glaab WE; Merck & Co, 770 Sumneytown Pike, West Point, PA, USA. Electronic address: .
Guffroy M; AbbVie, 1 North Waukegan Road, North Chicago, IL, USA. Electronic address: .
Harding J; AstraZeneca, Da Vinci Building, Melbourn Science Park, Cambridge Road, Melbourn, Royston, Hertfordshire, UK. Electronic address: .
Brees D; Novartis, 4057 Basel, Basel-stadt, Switzerland. Electronic address: .
McDuffie E; Janssen, 3210 Merryfield Row, San Diego, CA, USA. Electronic address: .
Ramaiah L; Pfizer, 401 North Middletown Road, Pearl River, NY, USA. Electronic address: .
Schultze AE; Lilly Research Laboratories, 893 S Delaware St, Indianapolis, IN, USA. Electronic address: .
Smith JD; Boehringer Ingelheim, 900 Ridgebury Rd, Ridgefield, CT, USA. Electronic address: .
Wolfreys A; UCB Biopharma, Bath Road, Slough, Berkshire, UK. Electronic address: .
Dalmas DA; GlaxoSmithKline, 1250 S. Collegeville Rd, Collegeville, PA, USA. Electronic address: .
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Źródło :
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Mar; Vol. 120, pp. 104857. Date of Electronic Publication: 2020 Dec 31.
Typ publikacji :
Journal Article
Język :
English
Imprint Name(s) :
Publication: <2003>- : Amsterdam : Elsevier
Original Publication: New York : Academic Press, [c1981-
Contributed Indexing :
Keywords: Clinical; DruSafe; Drug development; Emerging safety biomarkers; Nonclinical; Qualification; Survey
Entry Date(s) :
Date Created: 20210102 Latest Revision: 20210209
Update Code :
20210211
DOI :
10.1016/j.yrtph.2020.104857
PMID :
33387566
Czasopismo naukowe
Pharmaceutical and biotechnology companies rarely disclose their use of translational emerging safety biomarkers (ESBs) during drug development, and the impact of ESB use on the speed of drug development remains unclear. A cross-industry survey of 20 companies of varying size was conducted to understand current trends in ESB use and future use prospects. The objectives were to: (1) determine current ESB use in nonclinical and clinical drug development and impact on asset advancement; (2) identify opportunities, gaps, and challenges to greater ESB implementation; and (3) benchmark perspectives on regulatory acceptance. Although ESBs were employed in only 5-50% of studies/programs, most companies used ESBs to some extent, with larger companies demonstrating greater nonclinical use. Inclusion of ESBs in investigational new drug applications (INDs) was similar across all companies; however, differences in clinical trial usage could vary among the prevailing health authority (HA). Broader implementation of ESBs requires resource support, cross-industry partnerships, and collaboration with HAs. This includes generating sufficient foundational data, demonstrating nonclinical to clinical translatability and practical utility, and clearly written criteria by HAs to enable qualification. If achieved, ESBs will play a critical role in the development of next-generation, translationally-tailored standard laboratory tests for drug development.
(Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

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