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

  • Aug 9 2023
  • Duración: 9 m
  • Podcast

Regulatory CMC Considerations - Developing Modified Versions of Immediate Release Oral Solid Dosage Forms Por arte de portada

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

Escúchala gratis

Ver detalles del espectáculo

  • Resumen

  • 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.
    Más Menos
activate_primeday_promo_in_buybox_DT
Más Menos

Lo que los oyentes dicen sobre Regulatory CMC Considerations - Developing Modified Versions of Immediate Release Oral Solid Dosage Forms

Calificaciones medias de los clientes

Reseñas - Selecciona las pestañas a continuación para cambiar el origen de las reseñas.

Reseñas de Audible.com

Opiniones de Amazon
No hay comentarios disponibles