There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution …

Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, …

The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely …

Determine the acceptable performance of the dissolution test assembly periodically. The suitability for the individual apparatus is demonstrated by the Performance Verification Test. …

This guidance finalizes the guidance for industry on Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification …

2019年10月2日 · The primary functions of a dissolution test during early stages of development are to characterize therapeutic efficacy, bioequivalence, and bioavailability of API. During later …

2017年6月2日 · Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical …

2024年2月28日 · Dissolution testing provides critical information to support the realisation of drug release goals, for comparing the performance of different drug substances, for bioequivalence …