FDA
has issued a new guidance document: “Dissolution Testing and Acceptance
Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing
High Solubility Drug Substances Guidance for Industry”.
This
guidance is developed to provide manufacturers with recommendations for submission
of new drug applications (NDAs), investigational new drug applications (INDs),
or abbreviated new drug applications (ANDAs), as appropriate, for orally
administered immediate release (IR) drug products that contain highly soluble drug
substances. The guidance is intended to describe when a standard release test
and criteria may be used in lieu of extensive method development and acceptance
criteria-setting exercises.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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