Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

By Lawrence X. Yu, G. Amidon, J. Polli, Hong Zhao, M. Mehta, D. Conner, V. Shah, L. Lesko, Mei-ling Chen, V. H. Lee and 1 more. Pharmaceutical Research, 2002

612 citations recorded by the source corpus.

Subfields: Pharmaceutical Science, Pharmacology, Spectroscopy

View Paper: https://www.semanticscholar.org/paper/abb3e84633947eedd168c99b8c095e5c8d0f5822

How researchers see this paper

The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.

In Pharmaceutical Science

1. Christopher J. H. Porter
2. M. Brewster
3. W. Charman
4. Natalie L. Trevaskis
5. R. Shanker
6. S. Charman
7. H. Williams
8. Colin W. Pouton

In Pharmacology

1. L. Benet
2. W. Charman
3. Colin W. Pouton
4. Chi‐Yuan Wu
5. Christopher J. H. Porter
6. S. Charman
7. H. Williams
8. R. Shanker

In Spectroscopy

1. M. Brewster
2. Christopher J. H. Porter
3. W. Charman
4. S. Charman
5. H. Williams
6. R. Shanker
7. Natalie L. Trevaskis
8. T. Loftsson

Citations in the corpus

• Cyclodextrins as pharmaceutical solubilizers. (2007, background): “The BCS divides drugs and drug candidates into 4 classes based on their solubility and permeability characteristics [52–54].”
• Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control (2008, background): “Thus, the possibility of modification of these boundaries and criteria has received increasing attention ( 33 ,34).”
• Predicting Drug Disposition via Application of BCS: Transport/Absorption/ Elimination Interplay and Development of a Biopharmaceutics Drug Disposition Classification System (2004, background): “We find it inconsistent to suggest that products containing BCS Class 3 drugs should qualify for a waiver of in vivo bioequivalence studies on the basis of dissolution studies (5,15), when a large number of BCS Class 1 drugs cannot now qualify for the waiver due to the difficulty of proving that the”
• Pharmaceutical particle technologies: An approach to improve drug solubility, dissolution and bioavailability (2014, background): “When combined with in vitro dissolution characteristics of the drug product, BCS takes into account two major factors: solubility and intestinal permeability, which govern the rate and extent of oral drug absorption from solid dosage forms and ultimately, its bioavailability [8].”
• Strategies to Address Low Drug Solubility in Discovery and Development (2013, methodology): “The principles of the BCS are well described elsewhere (Amidon et al., 1995; Yu et al., 2002; Dahan et al., 2009), but in brief, the BCS allows classification of drug molecules as a function of their solubility and permeability properties.”