Related Articles Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies. Pharmazie. 2010 Mar;65(3):155-61 Authors: Mishra V, Gupta U, Jain NK Bioequivalence is a vital concern in drug development even more significant in the case of Narrow Therapeutic Index (NTI) drugs. In clinical development of New Chemical Entities (NCE), bioequivalence studies necessitate to be performed when the formulation of the pharmaceutical dosage form has been changed. In vivo pharmacokinetic data can be used as surrogate parameters for in vivo solubility and permeability data. The Biopharmaceutics Classification System (BCS) has emerged as a helpful tool in product development by alluding to the in vivo performance of the active substance. The bio-relevance of the BCS properties and the in vitro release are best expressed through a correlation between in vitro and in vivo data. Recently BCS has been implemented for waiving bioequivalence studies on the basis of the solubility and gastrointestinal permeability of drug substance and can be strategically deployed to save time and resources during generic drug development. The BCS has been adopted as a very useful tool for in vivo drug design and development worldwide, particularly in terms of regulatory standards. A BCS-based biowaiver has become an important and cost-saving tool in approval of generic drugs. PMID: 20383933 [PubMed - in process]
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Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence…
Related Articles Initiatives to enhance renin-angiotensin prescribing efficiency in Austria: impact and implications for other countries. Expert Rev Pharmacoecon Outcomes Res. 2010 Apr;10(2):199-207 Authors: Godman B, Bucsics A, Burkhardt T, Schmitzer M, Wettermark B, Wieninger P Aim: To assess the utilization of renin-angiotensin drugs, including combinations, in Austria in practice given the limited availability of diuretics, as well as the impact of recent reforms and initiatives on the utilization and expenditure of angiotensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs), following prescribing restrictions on ARBs immediately after their introduction. Methods: Utilization of dispensed prescriptions in ambulatory care was captured from 2001 to 2007 using defined daily doses as well as defined daily doses/1000 inhabitants/day for patients covered by the social health-insurance system. The data were provided by the internal data warehouse of Hauptverband der Osterreichischen Sozialversicherungsträger. Total costs in Euros were used for the analysis to facilitate comparisons with earlier studies. Results: There was appreciable utilization of fixed-dose diuretic combinations at between 36 and 38% of all renin-angiotensin products, in line with expectations. The reduction in expenditure/defined daily dose for originator and generic ACEis and their combinations is, again, in line with expectations, mirroring earlier findings for proton pump inhibitors and statins. ARB utilization was just under 27% of all renin-angiotensin products. This is higher than the low utilization rates seen with atorvastatin following its prescribing restrictions, and may reflect the difficulties if restrictions are based on subjective criteria. ARB utilization rates were lower or similar to other countries, who have implemented a different range of demand-side reforms to limit their prescribing with the advent of generic ACEis. Conclusion: The results confirm the successful implementation of the latest pricing policies and demand-side measures for generics and originators in Austria. We believe the prescribing restrictions for ARBs reduced their utilization in practice and offer an alternative approach to other demand-side measures. PMID: 20384566 [PubMed - in process]
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Initiatives to enhance renin-angiotensin prescribing efficiency in Austria:…
