We evaluated the pharmacokinetics of rectally administered zidovudine (ZDV) in 10 human immunodeficiency virus-infected adults. After rectal administration of an aqueous ZDV solution (250 mg of ZDV), mean peak ZDV levels were 1.3 +/- 0.7 micromol/liter (mean +/- standard deviation) versus 5.0 +/- 2.2 micromol/liter (P < 0.0001) after oral intake of a 250-mg ZDV capsule. The half-life at beta ph...

Alendronate sodium, a bisphosphonate drug, is used to treat osteoporosis and other bone diseases. The present study was designed to conduct comparative bioavailability analysis of oral formulations of alendronate sodium through an open-label, randomized, 2-sequence, 2-period crossover study. Healthy adult male Pakistani volunteers received a single 70mg dose of the test or reference formulation...

The aim of the study was to investigate the bioavailability of a generic product of 500 mg cefuroxime axetil film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both products. A double blinded, randomized, crossov...

We demonstrate the use of modeling and simulation to investigate bioequivalence (BE) concerns raised about generic warfarin products. To test the hypothesis that the loss of isopropyl alcohol and slow dissolution in acidic pH has significant impact on the pharmacokinetics of warfarin sodium tablets, we conducted physiologically based pharmacokinetic absorption modeling and simulation using form...

Six generic ciprofloxacin HCl 250 mg tablets from different manufacturer have been evaluated to assess their bioequivalence using in vitro tests. Other general quality assessments of these tablets like assay, weight variation, hardness, friability, disintegration time were also determined and all these generic tablets passed compendial specifications. There were no significant differences (p < ...

In a three-way cross-over study the bioavailability of cefuroxime was determined in 12 healthy volunteers after oral administration of 250 mg as cefuroxime axetil (Elobact; CAS 64544-07-6) in a plain aqueous suspension and as tablets from different batches. The tablet formulations showed nearly identical pharmacokinetic parameters and were bioequivalent. The mean maximum serum concentration was...

Background: The aim was determining bioequivalence between pantoprazole buffered powder for oral suspension and enteric coated tablets under fasting conditions in healthy volunteers.Methods: In randomized cross-over study, participants were administered a single dose of as 40 mg (sodium bicarbonate buffer) or one tablet mg, with 240±2 ml water per the randomization schedule each study period. B...

BACKGROUND To investigate the biological radiation dose-response for patients of limited-stage small-cell lung cancer (LS-SCLC) treated with high radiation dose. METHODS Two hundred and five patients of LS-SCLC treated with sequential chemotherapy and thoracic radiotherapy with involved-field between 1997 and 2006 were reviewed retrospectively. Biologically effective dose (BED) was calculated...

Isosorbide dinitrate (ISDN) is an effective drug in treatment of angina pectoris. In this study a new generation of electron capture detector (non-radioactive) with a short, non-polar and wide-bore column was used for analysis of ISDN in human serum. ISDN was extracted from serum by a mixture of ether and ethyl acetate and concentrated at room temperature. The method was linear between 5-50...

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 ...