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...

Fluoxetine drops and marketed fluoxetine capsules had quite the same Cmax (50.25 +/- 4.43 vs 47.55 +/- 5.29 ng/ml), but significantly different AUC0-t (717.27 +/- 71.29 vs 644.91 +/- 78.91 ng/ml/h). Furthermore the drops were characterised by a very early Tmax (4.61 +/- 0.85 hours) with a highly significant difference in comparison to the capsules reference compound (6.72 +/- 1.23 hours). After...

NEW DRUGS Generic Fludara for Leukemia Bioniche Pharma has received the FDA’s approval for its Abbreviated New Drug Application (ANDA) for fludarabine phosphate injection USP, 25 mg/ mL. The product is packaged in 50-mg/ 2-mL, single-dose vials. Fludarabine is a chemotherapy agent for treating B-cell chronic lymphocytic leukemia (CLL). The product is bioequivalent and therapeutically equivalent...

BACKGROUND Allergen extracts may be different due to the difference in dissemination of allergen-containing species in various geographical areas. Therefore, we wish to develop our own extracts to ensure the precision and quality of diagnosis. OBJECTIVES To compare the efficacy and safety of our locally prepared pollen allergen extracts to imported ones, using skin prick testing (SPT) and ser...

A greenhouse gas (GHG) emission model was developed based on economic and energy sector development at the national level. Different development scenarios were established, including BAU (scenario with business as usual) and API (scenario with additional policy interventions). We simulated annual GHG emissions under different scenarios for the EU, US, China, and India from 2016 to 2060, and eva...

To assess the comparative bioavailability of two cyclosporine capsule products with different pharmaceutical formulation an open randomized two-period cross over study was conducted in 24 healthy volunteers. Our results, obtained from cyclosporine HPLC determination onto the whole blood samples collected, show that the test cyclosporine non-SMEDDS formulation was not bioequivalent cyclosporine ...

The generic drug and branded drug is a confusing concept, and is a matter of serious concern for the pharmaceutical sector after the imposition of the rule that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs. The generic drug should be bioequivalent before they can...

The inhalational drug market, especially the generic market, has a tremendous growth potential globally (GBI Research, 2011; Espicom, 2013; Transperancy: Market Research, 2013). Generics are drugs that are bioequivalent to the approved drugs. The United States Food and Drug Administration (FDA) has defined bioequivalence as (U.S. FDA, 2014), “The absence of a significant difference in the rate ...