Establishment of a clinically relevant specification for dissolution testing using physiologically based pharmacokinetic (PBPK) modeling approaches.

In conclusion, a CRS was established with the BE simulation by using the verified PBPK model, in order to detect and reject non-BE batches of drug products. The establishment of the CRS is useful for a quality control and finding optimal formulation to accomplish target PK behavior, safety, and efficacy.
PMID: 32298756 [PubMed - as supplied by publisher]

Source: European Journal of Pharmaceutics and Biopharmaceutics - April 12, 2020 Category: Drugs & Pharmacology Authors: Kato T, Nakagawa H, Mikkaichi T, Miyano T, Ando S, Matsumoto Y Tags: Eur J Pharm Biopharm Source Type: research