Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms
| Autor: | Andre Hermans, Andreas Abend, Limin Zhang, Dorys Argelia Diaz, Talia Flanagan, Gregory K. Webster, Haiyan Grady, Filippos Kesisoglou, Michael J. Cohen, David A. Hahn, Carrie A. Coutant, Yiqing Lin, Yun Mao |
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| Rok vydání: | 2017 |
| Předmět: |
Therapeutic window
Computer science business.industry Pharmacology toxicology Pharmaceutical Science Administration Oral Context (language use) 02 engineering and technology Pharmacology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Models Biological Food and drug administration 03 medical and health sciences 0302 clinical medicine Risk analysis (engineering) Solubility New product development Humans Regulatory agency Immediate release 0210 nano-technology business Tablets |
| Zdroj: | The AAPS journal. 19(6) |
| ISSN: | 1550-7416 |
| Popis: | This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the development of CRS for IR products containing active ingredients with a non-narrow therapeutic window is discussed, within the context of mechanistic dissolution understanding, supported by in-human pharmacokinetic (PK) data. Two case studies present potential outcomes of following the CRS roadmap and setting dissolution specifications. These cases reveal some benefits and challenges of pursuing CRS with additional PK data, in light of current regulatory positions, including that of the US Food and Drug Administration (FDA), who generally favor this approach, but with the understanding that both industry and regulatory agency perspectives are still evolving in this relatively new field. The CRS roadmap discussed in this manuscript also describes a way to develop clinically relevant dissolution specifications based primarily on dissolution data for batches used in pivotal clinical studies, acknowledging that not all IR product development efforts need to be supported by additional PK studies, albeit with the associated risk of potentially unnecessarily tight manufacturing controls. Recommendations are provided on what stages during the life cycle investment into in vivo studies may be valuable. Finally, the opportunities for CRS within the context of post-approval changes, Modeling and Simulation (M&S), and the application of biowaivers, are briefly discussed. |
| Databáze: | OpenAIRE |
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