Bioequivalence and Bioavailability Forum

Dear Kuldeep Namdev
What do you mean by liquid formulation? Solution or suspension for oral administration, for intravenous, subcutaneous or intramuscular administration?
The FDA Guidance for Industry “Handling and Retention of BA and BE Testing Samples” (CDER May 2004) states that “The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application. The rationale for requiring the five times quantity is provided in the final rule. The clinical investigator can obtain the amount that constitutes the five times quantity from the sponsor and/or drug manufacturer. For solid oral dosage forms (e.g., tablets, capsules), an upper limit of 300 units each for the test article and reference standard can be considered sufficient to meet the five times quantity. Because the Agency has limited experience with the retention and testing of non-solid oral dosage forms, the Agency is unable to recommend an upper limit for the retention of non-solid oral dosage forms at this time.”
Kind regards
Dr_Dan