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Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations
Authors:Rong-Kun Chang  Neil Mathias  Munir A. Hussain
Affiliation:1.Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research,US Food and Drug Administrations,Silver Spring,USA;2.Drug Product Science & Technology,Bristol-Myers Squibb Co.,New Brunswick,USA
Abstract:This article discusses the range of outcomes from biopharmaceutical studies of specific modified release (MR) product examples in preclinical models and humans. It touches upon five major biopharmaceutical areas for MR drug products: (1) evidence for regional permeability throughout the GI tract, (2) susceptibility to food-effect, (3) susceptibility to pH-effect, (4) impact of chronopharmacology in designing MR products, and (5) implications to narrow therapeutic index products. Robust bioperformance requires that product quality is met through a thorough understanding of the appropriate critical quality attributes that ensure reliable and robust manufacture of a MR dosage form. The quality-by-design (QbD) aspects of MR dosage form design and development are discussed with the emphasis on the regulatory view of the data required to support dosage form development.
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