Demonstrating suitability of the Caco‐2 cell model for BCS‐based biowaiver according to the recent FDA and ICH harmonised guidelines

According to the regulatory guidelines, one of the critical steps in using in‐vitro permeability methods for permeability classification is to demonstrate the suitability of the method. Here, suitability of the permeability method by using a monolayer of cultured epithelial cells was verified with different criteria.

• Publication year

  2019

• Venue

  The Journal of pharmacy and pharmacology

• Publication date

  2019-08-01

• Fields of study

  Medicine, Chemistry

• Identifiers
  DOI 10.1111/jphp.13111PMID 31155721
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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