BCS Classification Share this page is a classification of drugs depending on their permeability and Solubility to improve the efficiency of drug development and strategy for identifying expendable clinical bioequivalence tests.Thare are four categories of drugs in which class 1 drugs, class 2 drugs,class 3 drugs, and class 4 drugs. Related Journals Journal of Therapeutic Advances in Drug Safety; Journal of Investigational New Drugs; Journal of Pharmaceutical Research; Journal of Drugs; Drug Metabolism Reviews; Journal of Pharmacology and Therapeutics BCS Classification.

Biopharmaceutical Classification System and Formulation Development Particle Sciences - Technical Brief: 2011: Volume 9 The Biopharmaceutical Classification System (BCS) is an experimental model that measures permeability and solubility under prescribed conditions. The original purpose of the system was to aid in the regulation of post-approval changes and generics, providing approvals based solely on in vitro data when appropriate. Importantly, the system was designed around oral drug delivery since the majority of drugs are and remain orally dosed.

Davit, June 2011, ‘BCS Classification Workshop, Canadian Society for Pharmaceutical Sciences ‘FDA Experience with Biopharmaceutics Classification System (BCS) Biowaivers New Drugs vs. Generics Between 2003 – June, 2011, 54 drug products submitted to FDA for classification. Criteria for BCS based biowaiwers: Biowaiver are based on the Biopharmaceutics (BCS) classification of the active ingredient. Currently BCS class I and some class III compounds are eligible for biowaivers. • The drug substance should be highly soluble and highly permeable.

Waivers, permission to skip in vivo bioequivalence studies, are reserved for drug products that meet certain requirements around solubility and permeability and that are also rapidly dissolving. More and more however, the industry is using the BCS as a tool in drug product development. As a simple example, BCS can be used to flag drugs that should not be tested clinically unless appropriate formulation strategies are employed (see Figure 1). As an example, a BCS Class II compound, permeable but relatively insoluble, would likely not be a good clinical candidate without the use of enhanced formulation techniques aimed at increasing solubility or rate of dissolution. Various schemes exist that attempt to funnel a given API towards particular drug delivery techniques depending on the API’s BCS category. Still, most approaches remain fragmented in their methodology, ignoring commercially and biologically important factors.

The BCS can however, when integrated with other information provide a tremendous tool for efficient drug development. One school of thought, very much endorsed by the authors, is that first in human (FIH) drug dosage forms should be designed to maximize bioavailability and that the FIH dosage form should be a logical step towards commercialization and not simply a stop gap to facilitate data acquisition. This makes sense both economically and ethically. Vijay tv mahabharatham mp3 all cut tamil songs. For BCS Class I molecules, FIH formulations are straight forward and may consist of essentially the neat API.