Bioequivalence and Bioavailability Forum

❝ […] I have been unable to find the relevant Reference Product of Tripolidine for Malaysia.

• The selection of comparator product should be based on the selection criteria of ASEAN comparator product as follows:
  
  
  1. Innovator product and multiple manufacturing sites of the same innovator registered in the country is acceptable.
     
  2. If the innovator product used as comparator is not registered in the country, justification is required from the generic company to prove its interchangeability with the registered innovator (in vitro or in vivo).
     
  3. If the innovator product cannot be identified, the choice of comparator must be made carefully and be comprehensively justified by the applicant. The selection criteria of a comparator in order of preference are:
     • Approval in ICH and associated countries
       
     • Pre-qualified by WHO
     A well selected comparator must conform to compendia quality standards, if applicable.

• It is recommended to clarify with the regulatory authority regarding the choice of comparator product before the bioequivalence study is conducted.