دورية أكاديمية
Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective.
| العنوان: | Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective. |
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| المؤلفون: | Wu C; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Lee SL; Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Taylor C; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Li J; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Chan YM; Botanical Review Team, Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Agarwal R; New Drug Products Branch II, Division of New Drug Products I, Office of New Drug Products, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Temple R; Office of the Center Director , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Throckmorton D; Office of the Center Director , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States., Tyner K; Science Staff, Immediate Office, Office of Pharmaceutical Quality , Center for Drug Evaluation and Research, Food and Drug Administration , 10903 New Hampshire Avenue , Silver Spring , Maryland 20993 , United States. |
| المصدر: | Journal of natural products [J Nat Prod] 2020 Feb 28; Vol. 83 (2), pp. 552-562. Date of Electronic Publication: 2020 Jan 24. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Pharmacognosy Country of Publication: United States NLM ID: 7906882 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6025 (Electronic) Linking ISSN: 01633864 NLM ISO Abbreviation: J Nat Prod Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Cincinnati, American Society of Pharmacognosy. |
| مواضيع طبية MeSH: | Investigational New Drug Application*, Proanthocyanidins/*chemistry, Humans ; Molecular Structure ; Pharmaceutical Preparations ; United States |
| مستخلص: | The United States FDA has received over 800 botanical investigational new drug applications (IND) and pre-IND meeting requests (PIND) in the years preceding 2018. The current data show that indications for submitted INDs cover nearly every review division of the FDA. Despite increasing global interest in the investigation of botanical mixtures as drug products, only two botanical new drug applications (NDA) have been approved in the U.S.: Veregen in 2006 and Fulyzaq (also known as Mytesi) in 2012. Given botanicals' chemical and biological complexity, efforts in characterizing their pharmacology, demonstrating therapeutic efficacy, and ensuring quality consistency remain scientific and regulatory challenges. The FDA published a revised Botanical Drug Development Guidance for Industry document in December 2016 to address developmental considerations for late-phase trials and to provide recommendations intended to facilitate botanical drug development. Herein, we present an analysis of botanical INDs showing their variety of botanical raw materials (e.g., coming from different geographic regions, single vs multiple herbs), the varied levels of previous human experience, and therapeutic areas, as well as provide an overview of experience and challenges in reviewing botanical drugs. |
| المشرفين على المادة: | 0 (Pharmaceutical Preparations) 0 (Proanthocyanidins) PY79D6C8RX (crofelemer) |
| تواريخ الأحداث: | Date Created: 20200125 Date Completed: 20210305 Latest Revision: 20210305 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1021/acs.jnatprod.9b00949 |
| PMID: | 31977211 |
| قاعدة البيانات: | MEDLINE |
Find this issue from the American Chemical Society | تدمد: | 1520-6025 |
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| DOI: | 10.1021/acs.jnatprod.9b00949 |