Is analytical validation information required for the assay of the API in the FPP 1.58K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K September 29, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 29, 2020 0 Comments Spread the loveIf assay is pharmacopoeial (Ph.Int., USP, JP or BP), only evidence of specificity (with respect to effects of placebo) and method precision should be submitted. Additional validation data is required if an in-house method is used. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
