Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development
| Autor: | Min Li, Bhagwant D. Rege, Paul Seo, Sanna Sander, John Duan, Susan Rosencrance, Lawrence X. Yu, Sarah Pope Miksinski |
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| Rok vydání: | 2016 |
| Předmět: |
Quality Control
Process (engineering) Computer science media_common.quotation_subject Chemistry Pharmaceutical Pharmaceutical Science Administration Oral 030226 pharmacology & pharmacy Biopharmaceutics 03 medical and health sciences 0302 clinical medicine Drug Discovery Animals Humans Quality (business) Product (category theory) media_common Clinical performance Patient benefit Risk analysis (engineering) Solubility 030220 oncology & carcinogenesis Delayed-Action Preparations Drug product Critical quality attributes |
| Zdroj: | The AAPS journal. 18(6) |
| ISSN: | 1550-7416 |
| Popis: | This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures. |
| Databáze: | OpenAIRE |
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