Since its inception in 1995, the biopharmaceutical classification system (BCS) has become an increasingly important tool for regulation of drug products world-wide. Until now, application of the BCS has been partially hindered by the lack of a freely available and accurate database summarising solubility and permeability characteristics of drug substances. The BCS (Biopharmaceutics Classification System)-based biowaiver approach is meant to reduce in vivobioequivalence studies, i.e., it may represent a surrogate for in vivobioequivalence. In vivobioequivalence studies may be exempted if an assumption of equivalence in in vivo. 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. Classification (see below), a BCS -based biowaiver application can be made without providing data for classification of the API; and (2) for products containing APIs not included in the table below, a BCS -based biowaiver application.
FAQs
Can online education replace traditional education?
While e-learning won't replace traditional classrooms, it will change the way we know them today. With improved resources and reduced teacher workloads, classrooms can shift to co-learning spaces. Students can arrive, learn, engage—all at their own pace in a collaborative environment.
Is online school a good idea?
Yes, online schooling is the best idea for every learner. Online students may participate in live interactions and real-time feedback for such things as quizzes and tests. Instructor and student exchanges occur in the virtual world through such methods as chat, e-mail or other web-based communication.
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Yes. It is a good idea to put Relevant completed online courses on your resume, especially if you have a certificate for it. In the Education section, write about your formal education - namely, your Bachelor and Masters degrees.
What skills are needed for online learning?
You need to have a basic knowledge of computer and Internet skills in order to be successful in an online course
Bcs Classification System Database
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.
About BCS — Drug Delivery Foundation
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.
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.
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
Bcs Classification List
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]