Demonstration of bioequivalence for TB medicines . Milan Smid, MD, PhD. Tutorial: Quality of Pharmaceutical Ingredients, TB medicines, Beijing, 31 March, 2010.
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Milan Smid, MD, PhD
Tutorial: Quality of Pharmaceutical Ingredients, TB medicines, Beijing, 31 March, 2010
Drug particle size, ..
Site of manufacture
Batch size ….
= Therapeutic Equivalence
(Note: Generally, same dissolution specifications)
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protected, consistent with the principles
that have their origin in the Declaration
of Helsinki, and that the
clinical trial data are credible.
Information for Applicants
Generics, ANNEX 7:
Presentation of Bioequivalence Trial Information
Ethambutol (BCS 3), Isoniazid (BCS 3/1), Pyrazinamide (BCS 3/1)
Levofloxacin (BCS 1), Ofloxacin (BCS 1)
Designed to facilitate information exchange between the Applicant and the WHO Prequalification of Medicines Programme if the Applicant seeks to waive bioequivalence studies, based on the Biopharmaceutics Classification System (BCS).
For further information, please study the respective WHO biowaiver guidance documents. This form is not to be used, if a biowaiver is applied for additional strength(s) of the submitted product(s), in which situation a separate "Biowaiver Application Form: Additional Strengths" should be used.