- Bcs Classification Database Fda
- Bcs Classification System Database
- Biopharmaceutics Classification System - Wikipedia
FDA has issued a final guidance entitled Waiver of In-vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. BCS (Biopharmacetical Classification System) classifies the drug based on solubility. Permeability of a drug, based on which there are four classes. A drug substance is considered HIGHLY SOLUBLE when the highest dose strength is soluble in. The Biopharmaceutical Classification System (BCS) has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with.
August 26, 2020
Our file number: 20-109235-116
Our file number: 20-109235-116
Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9: Biopharmaceutics Classification System (BCS) Based Biowaivers. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. In implementing the ICH M9 guideline, it replaces the Health Canada guidance document: Biopharmaceutics Classification System Based Biowaiver. It is recommended that the Health Canada BCS Based Biowaiver Evaluation Template be completed for drug submissions that include a biowaiver request.
As per its commitment to ICH as a standing member, Health Canada is implementing this guidance with no modifications. In implementing this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other Guidance documents are available on the ICH Website. Lightroom 2019 mac torrent net. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.
Should you have any questions or comments regarding the content of the guidance, please contact:
The “Waiver of In-vivoBioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System” is an FDA guidance document, which allows pharmaceutical companies to forego clinical bioequivalence studies, if their drug product meets the specification detailed in the guidance.
The principles of the BCS classification system can be applied to NDA and ANDA approvals as well as to scale-up and post approval changes in drug manufacturing. A waiver of In-vivo Bioavailability and Biioequivalence studies based on the BCS classification can therefore save pharmaceutical companies a significant amount of development time and reduce development costs.
The BCS classification system is based on the scientific rationale that, if the highest dose of a drug candidate is readily soluble in the average fluid volume present in the stomach (250 ml) and the drug is more than >85% absorbed, then the in vitro drug product dissolution profiles should allow assessment of the equivalence of different drug formulations. Solubility and dissolution can be easily measured in vitro. Extent of absorption has historically been determined by conducting mass balance studies both preclinically and clinically.
Bcs Classification Database Fda
However, our work and that of our collaborators has demonstrated that the effective intestinal permeability (Peff) of therapeutic agents correlates well with total fraction absorbed in both humans, rats, and to a lesser extent in vitro tissue culture systems (1-5). Based on these studies a drug candidate can fall into one of four BCS categories, with category I, High Permeability and High Solubility, being the subject of the BCS guidance. The WHO has recently recommended biowaivers for Class III and some Class II drugs and AAPS-FDA scientific conferences have recommended biowaivers for Class III compounds as well.
Bcs Classification System Database
References:
- GL Amidon et al., Pharm Res Vol 12(3): 413-420, 1995
- A Dahan et al., Molecular Pharmaceutics, Vol 10(11): 4378-4390, 2013 (http://pubs.acs.org/doi/abs/10.1021/mp400485k)
- X Cao et al, Pharm Res Vol 23(8):1675-1686, 2006
- H Lennernas at al., Pharm Res Vol 14(5): 667-671, 1997
- P Artursson and J Karlson, Biochem Biophys Res Comm. Vol175(3): 880-885, 1991
Biopharmaceutics Classification System - Wikipedia
For more information, please contact:
Gordon Amidon, PhD
TSRL, Inc.
540 Avis Drive, Suite A
Ann Arbor, MI 48108
Phone: (734) 663-4233 x222
E-mail: [email protected]
Gordon Amidon, PhD
TSRL, Inc.
540 Avis Drive, Suite A
Ann Arbor, MI 48108
Phone: (734) 663-4233 x222
E-mail: [email protected]