ICH Proposes Harmonized Bioequivalence Standards For Solid Oral Drugs
The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.
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For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.
The ICH has published a reflection paper on harmonizing technical and scientific standards for generics that envisages initially developing guidelines on bioequivalence standards for non-complex oral dosage forms, followed by guidance on more complex dosage forms or products. A discussion group will also be established to identify opportunities to include generics in other ICH guidelines.
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