Investigation of Bioavailability and Bioequivalence
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چکیده
Additional Notes This note for guidance concerns the application of Part 4, section E of the Annex to Directive 75/318/EEC as amended and Article 4,2 point 8 of Directive 65/65/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product. It defines when bioavailability or bioequivalence studies are necessary for immediate release products with a systemic effect and formulates requirements for the design, conduct and evaluation of these studies.
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Comparative Bioavailability of Ranitidine Tablets in Healthy Volunteers
The pharmacokinetic parameters of domestic and imported ranitidine hydrochloride tablets (Ranitidine, formulated and manufactured by Kharazmi Pharmaceuticals, Iran, and Zantac ? manufactured by Glaxo, UK) were measured in 14 healthy subjects following oral administration of a single 300-mg dose of each brand and compared for bioequivalence evaluation. The pharmaceutical equivalency of both fo...
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Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products. In this study, we sought to systematically assess the current trends of ongoing and recently completed bioequivalence and bioavailability trials that have been registered within a nation...
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The pharmacokinetic parameters of domestic and imported ranitidine hydrochloride tablets (Ranitidine, formulated and manufactured by Kharazmi Pharmaceuticals, Iran, and Zantac ? manufactured by Glaxo, UK) were measured in 14 healthy subjects following oral administration of a single 300-mg dose of each brand and compared for bioequivalence evaluation. The pharmaceutical equivalency of both fo...
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متن کاملBioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers
The relative bioavailability of the test (generic) product 2 × 25 mg baclofen tablets, with respect to the reference product, Lioresal® 2 × 25 mg tablets (baclofen; Squibb) was determined in a single-blind, single dose, randomised, crossover study. The mean values for the variable Cmax were 737.6 ng/ml for the reference and 739.5 ng/ml for the test product. The mean values for the variable AUC ...
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