FDA Issues Dissolution Testing Guidance
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
FDA issued draft guidance on July 31, 2015 regarding dissolution testing for immediate-release solid oral dosage forms that contain biopharmaceutics classification system (BCS) class 1 and 3 drugs. The guidance, which applies to new drug applications, investigational new drug applications, and/or abbreviated new drug applications, provides recommendations for immediate-release (IR) tablets and capsules that contain highly soluble drug substances.
Specifically, the guidance describes when a standard release test and criteria may be used instead of extensive method development and specification-setting exercises. When finalized, the new guidance will supersede a 1997 guidance, Dissolution Testing for Immediate Release Solid Oral Dosage Forms, for BCS class 1 and 3 drug substances in IR drug products that meet the criteria in the new guidance. The 1997 guidance will still apply for class 2 and 4 drug substances.
Source: FDA
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF
July 25th 2025The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.
