- Search Courses By
- Search By Time
Boehringer Ingelheim classifies this drug substance as a Class III compound according to the Biopharmaceutical Classification System (BCS) because of its high solubility and low bioavailability.
Search BCS Search. Enter your keywords Search. Contact us Website feedback Accessibility. Data privacy notice. Dissolution Methods Database with BCS and BE v. 1.2.3.2 contains data: USP dissolution methods, FDA dissolution methods, FDA bioequivalence references, Drug Delivery Foundation Biopharmaceutical Classification System, USP Dietary Supplements dissolution methods, JP dissolution methods, Biowaiver monographs.
About bcs classification list
bcs classification list provides a comprehensive and comprehensive pathway for students to see progress after the end of each module. With a team of extremely dedicated and quality lecturers, bcs classification list will not only be a place to share knowledge but also to help students get inspired to explore and discover many creative ideas from themselves.Clear and detailed training methods for each lesson will ensure that students can acquire and apply knowledge into practice easily. The teaching tools of bcs classification list are guaranteed to be the most complete and intuitive.
Popular Search
› everett community college chs
› niagara district school board map
› reinforcement learning and optimal control pdf
› teacher in service training programs
› science learning center
› healthsciencescharterschool
› moo adaptive learning elementary school
Cached
› mfr therapy training
› powerpoint instructional teaching method
› is weight training enough cardio
› free coding classes for kids online
› art conscious learning
![Bcs Bcs](/uploads/1/1/0/4/110440583/489355289.jpg)
› best business colleges in canada
› pa school applications
› bridging the gap program virginia
› complete suture practice kit
› the piano lesson amazon
› mctc ky schedule of classes
› you dumb truck training day
› safety training sewing operators
Course Blogs
Yoyo ChineseYoyo Chinese is an online Chinese language education company focused on using clearlyexplained videos to teach Chinese to students from all over the world. With 20 million le...
What is yoga? Is it the same thing as exercise?Yoga is a type of spiritual and physical meditation that involves various poses. Originated in India, it is now practiced habitually all over the...
Learning web development now seems to be the trend. Many people are willing to spend a lot of money to have quality courses for it, however, there are also many 100% free web development courses that ...
Instead of making efforts for finding coupons for hunter safety courses, we can look for an affordable course from the beginning. Below is a list of the best places that you can find affordable hunter...
Insurance is quite tricky so getting to know about the insurance required a lot of research. In the changing time the protection and safety regarding the assets, business, and lives are very essen...
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.
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 Database Search
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]