Nevertheless, the HEC has evolved a procedure whereby it is able to meet these challenges and address all the complexities involved. SUBJECT: List of Products Requiring Bioequivalence (BE) Studies as Part of the.
With the proliferation of degree-awarding institutions – both in the private and public sectors – and given the diversity of taught programs and disciplines, the comparability and method of recognition for degrees has become more confusing In such a scenario, the equivalence of degrees and diplomas and their recognition pose complex issues for educational authorities. The accreditation of institutions, courses and degree programs has become increasingly challenging with increasing international collaboration in the fields of science and technology, as well as the increased mobility of students and scholars in the modern world. HEC revised the rates of equivalence fee for Local Degree/Deeni Asnads w.e.f. Our work is aimed at exploring the composition and the properties of microemulsion (ME), as a drug delivery system, to enhance the permeability across the. Classification of orally administered drugs on the World Health Organization Model List of Essential Medicines according to the biopharmaceutics classification.
Applicants are advised to apply for equivalence of their degrees at as no manual applications for equivalence of Pakistani or Foreign degrees will be accepted henceforth.Īdvisory for Admission in Foreign Medical Universities/Institutions products, can one of the drug substances qualify for a BCS-based biowaiver, while the other does not All drug substances in a fixed-dose combination product must fulfill the criteria for either BCS Class I or III to qualify for a biowaiver. Antiallergic drugs in Class 1, drugs for pain relief in Class 2 and antidiabetic drugs in Class 3 have received the largest number of approvals during this period.Higher Education Commission has launched online portal for equivalence of degrees. The Biopharmaceutics Classification System (BCS) is a theoretical scheme that categorizes drugs into four classes (Figure 1) considering their solubility.
The present data indicated a trend of more ANDA approvals of BCS Class 1 drugs than Class 3 or Class 2 drugs. BCS class IV drugs (e.g. This classification system is useful in predicting effects of efflux and uptake transporters on oral absorption as well as on postabsorption systemic levels following oral and intravenous dosing. Applying this list to evaluation of 263 ANDA approvals of BCS drugs during the period of 2000 to 2011 indicated 110 approvals (41.8%) for Class 1 drugs (based on both biowaiver and in vivo bioequivalence studies), 55 (20.9%) approvals for Class 2 drugs, 98 (37.3%) approvals for Class 3 drugs, and no (0%) approvals for Class 4 drugs. Journal of Controlled Release 2017 February 28, 248: 71-95. BDDCS (Biopharmaceutical Drug Disposition and Classification System) divides compounds into four classes based on their permeability and solubility.
To categorize solubility and intestinal permeability properties of generic drugs under development, we used a list of 61 drugs which were classified as BCS 1, 2, 3, and 4 drugs with certainty in the World Health Organization Model List of Essential Medicines. BCS Class IIa drugs, typically carboxylic acids with a p K a in the range of 4 to 5, are insoluble at typical, fasted, gastric pHs but soluble at intestinal pHs and, hence, are classified as BCS Class II or IV depending on intestinal jejunal permeability at pH 6.5 or fraction dose absorbed determination in humans. BCS class IV drugs (e.g. The objective of this study was to use the World Health Organization Model List of Essential Medicines to determine the distribution of BCS Class 1, 2, 3, and 4 drugs in Abbreviated New drug Applications (ANDA) submissions. The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. poor dissolution rate of BCS Class II and IV drugs. The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. increase the solubility of the BCS Class II model drug spironolactone when.