Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality

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• 作者：Adam C. Fisher^a ; Sau L. Lee^a ; ^{sau.lee@fda.hhs.gov} ; Daniel P. Harris^a ; Lucinda Buhse^a ; Steven Kozlowski^a ; Lawrence Yu^a ; Michael Kopcha^a ; Janet Woodcock^b
• 关键词：ADF ; abuse deterrent formulation ; API ; active pharmaceutical ingredient ; T-DM1 ; Ado-Trastuzumab Emtansine ; ADC ; antibody-drug conjugate ; CDER ; center for drug evaluation and research ; CBRN/EID ; chemical ; biological ; radiological/nuclear and emerging infectious disease ; CMC ; chemistry ; manufacturing ; and controls ; DMD ; Duchenne muscular dystrophy ; DLS ; dynamic light scattering ; FDA ; food and drug administration ; FTIR ; Fourier transform infrared spectroscopy ; GA ; glatiramer acetate ; IVIVC ; in vivo
• 刊名：International Journal of Pharmaceutics
• 出版年：2016
• 出版时间：30 December 2016
• 年：2016
• 卷：515
• 期：1-2
• 页码：390-402
• 全文大小：3235 K
• 卷排序：515

文摘

Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public.