• Regulatory CMC Considerations - Developing Modified Versions of Immediate Release Oral Solid Dosage Forms

  • 2023/08/09
  • 再生時間： 9 分
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Regulatory CMC Considerations - Developing Modified Versions of Immediate Release Oral Solid Dosage Forms

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  • When developing modified-release oral solid dosage forms, important considerations include selecting the appropriate release mechanism, establishing the optimal release profile, understanding regulatory requirements, addressing CMC considerations related to formulation, manufacturing, and testing, considering BCS classification and biowaiver, developing a clinical development plan, and protecting intellectual property. API characterization and pre-formulation work provide benefits such as improved understanding of API properties, identification of formulation challenges, support for regulatory submissions, enhanced process understanding, better manufacturing control, and improved prediction of product performance in the human body. Health authorities expect to see key CMC development data, including formulation details, manufacturing processes, analytical method development and validation, stability information, in-vitro release studies, BCS classification and biowaiver status, clinical development plan and data, and comparative data. These data are necessary to demonstrate the suitability and quality of the modified release product for regulatory approval.
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あらすじ・解説

When developing modified-release oral solid dosage forms, important considerations include selecting the appropriate release mechanism, establishing the optimal release profile, understanding regulatory requirements, addressing CMC considerations related to formulation, manufacturing, and testing, considering BCS classification and biowaiver, developing a clinical development plan, and protecting intellectual property. API characterization and pre-formulation work provide benefits such as improved understanding of API properties, identification of formulation challenges, support for regulatory submissions, enhanced process understanding, better manufacturing control, and improved prediction of product performance in the human body. Health authorities expect to see key CMC development data, including formulation details, manufacturing processes, analytical method development and validation, stability information, in-vitro release studies, BCS classification and biowaiver status, clinical development plan and data, and comparative data. These data are necessary to demonstrate the suitability and quality of the modified release product for regulatory approval.
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