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.
You may also be interested in...
The International Council for Harmonisation has unveiled plans to develop and publish several new guidance documents, including one on bioequivalence for modified-release products, which has been welcomed by global off-patent industry body the IGBA.
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.