Abstract
The biopharmaceutic classification system (BCS) uses the two factors that govern the rate and extent of drug absorption: solubility and intestinal permeability. The main objective of the BCS was to predict in vivo pharmacokinetic behaviour of drug products using measurements of permeability and solubility. In 2016, the International Council for Harmonisation endorsed the development of a new globally harmonised guideline on BCS-Based Biowaivers. The scientific basis of the BCS, emphasised by the regulatory endorsed BCS-based biowaivers, has led to the BCS being used within pharmaceutical development. The Developability Classification System is an adaptation of the BCS, introduced in 2010 as a tool for application to formulation development. During development BCS classification allows scientists to anticipate the potential issues, develop strategy, and prioritise resources for pharmaceutical development.
| Original language | English |
|---|---|
| Title of host publication | Biopharmaceutics |
| Subtitle of host publication | From Fundamentals to Industrial Practice |
| Editors | Hannah Batchelor |
| Pages | 135-146 |
| Number of pages | 12 |
| ISBN (Electronic) | 9781119678366 |
| DOIs | |
| Publication status | Published - 28 Jan 2022 |
Keywords
- BCS-based biowaivers
- biopharmaceutic classification system
- developability classification system
- drug absorption
- drug products
- drug solubility
- intestinal permeability
- pharmaceutical development