Please let me know if bioavailability or bioequivalance studies required for the injections to be used via iv, Im, subcutaneous . Thank you in andvance.
The following type of multisource pharmaceutical product is considered
to be equivalent without the need for further documentation:
When the pharmaceutical product is to be administered parenterally
(e.g. intravenously, subcutaneously or intramuscularly) as an aqueous
solution containing the same API in the same molar concentration as
the comparator product and the same or similar excipients in comparable
concentrations as in the comparator product in such case. Certain excipients
(e.g. buffer, preservative and antioxidant) may be different provided it
can be shown that the change(s) in these excipients would not affect the
safety and/or effi cacy of the pharmaceutical product.
Ref: WHO- MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: GUIDELINES ON REGISTRATION REQUIREMENTS TO ESTABLISH INTERCHANGEABILITY
Dear Ussidaho,
Thank you so much for the extensive and explanatory response.
There can be certain exceptions where due to complex or heavy molecular structure of API if only essential similarities with the reference product does not prove its pharmacokinetic behavior, agency will recommend BE study even it is I.v. injectable product.