select ad.sno,ad.journal,ad.title,ad.author_names,ad.abstract,ad.abstractlink,j.j_name,vi.* from articles_data ad left join journals j on j.journal=ad.journal left join vol_issues vi on vi.issue_id_en=ad.issue_id where ad.sno_en='9646' and ad.lang_id='6' and j.lang_id='6' and vi.lang_id='6' Statistical Designs for Pharmaceutical/Clinical Development | 9646
医薬品設計: オープンアクセス

医薬品設計: オープンアクセス
オープンアクセス

ISSN: 2169-0138

概要

Statistical Designs for Pharmaceutical/Clinical Development

Shein-Chung Chow and Annpey Pong

In recent years, the concept of quality by design in (global) pharmaceutical development has received much attention. The purpose is to ensure that the compound under investigation will possess good drug characteristics such as identity, strength, purity, quality, safety, efficacy and stability before and post approval. A pharmaceutical development process consists of non-clinical (e.g., assay/process validation and stability testing), pre-clinical (e.g., animal and bioavailability/bioequivalence studies), and clinical (e.g., phases 1-3 clinical trials) development. In this article, various statistical designs that are commonly considered for achieving desired good drug characteristics as described in the United States Pharmacopeia and National Formulary (USP/NF) at various stages of non-clinical, pre-clinical, and clinical development are reviewed. In addition, the possible use of innovative adaptive clinical trial designs that may lead to (i) the identification of any signals, trends/patterns, and optimal clinical benefits of a test treatment under investigation, and (ii) increase the probability of success of the development process with limited resources available are discussed.

免責事項: この要約は人工知能ツールを使用して翻訳されたものであり、まだレビューまたは検証されていません。
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