Remove Bioequivalency Remove In-Vivo Remove Packaging Remove Production
article thumbnail

A PSA on PSGs: PSG Meetings Are Now Available

FDA Law Blog

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

article thumbnail

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.