دورية أكاديمية
An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).
| العنوان: | An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs). |
|---|---|
| المؤلفون: | Avila AM; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Bebenek I; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Bonzo JA; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Bourcier T; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Davis Bruno KL; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Carlson DB; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Dubinion J; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Elayan I; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Harrouk W; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Lee SL; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Mendrick DL; National Center for Toxicological Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Merrill JC; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Peretz J; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Place E; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Saulnier M; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Wange RL; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Yao J; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Zhao D; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States., Brown PC; Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20903, United States. Electronic address: Paul.Brown@fda.hhs.gov. |
| المصدر: | Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Jul; Vol. 114, pp. 104662. Date of Electronic Publication: 2020 Apr 20. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2003>- : Amsterdam : Elsevier Original Publication: New York : Academic Press, [c1981- |
| مواضيع طبية MeSH: | Pharmaceutical Preparations/*chemistry, Animals ; Drug Development ; Humans ; Risk Assessment ; United States ; United States Food and Drug Administration |
| مستخلص: | Nonclinical testing of human pharmaceuticals is conducted to assess the safety of compounds to be studied in human clinical trials and for marketing of new drugs. Although there is no exact number and type of nonclinical studies required for safety assessments, as there is inherent flexibility for each new compound, the traditional approach is outlined in various FDA and ICH guidance documents and involves a combination of in vitro assays and whole animal testing methods. Recent advances in science have led to the emergence of numerous new approach methodologies (NAMs) for nonclinical testing that are currently being used in various aspects of drug development. Traditional nonclinical testing methods can predict clinical outcomes, although improvements in these methods that can increase predictivity of clinical outcomes are encouraged and needed. This paper discusses FDA/CDER's view on the opportunities and challenges of using NAMs in drug development especially for regulatory purposes, and also includes examples where NAMs are currently being used in nonclinical safety assessments and where they may supplement and/or enhance current testing methods. FDA/CDER also encourages communication with stakeholders regarding NAMs and is committed to exploring the use of NAMs to improve regulatory efficiency and potentially expedite drug development. Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2020 Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Alternative; Approach; Drug development; FDA; In vitro; Methodology; Regulatory |
| المشرفين على المادة: | 0 (Pharmaceutical Preparations) |
| تواريخ الأحداث: | Date Created: 20200424 Date Completed: 20210223 Latest Revision: 20210223 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1016/j.yrtph.2020.104662 |
| PMID: | 32325112 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1096-0295 |
|---|---|
| DOI: | 10.1016/j.yrtph.2020.104662 |