The introduction of cyclosporine (CsA) in clinical practice has significantly improved patient and allograft survival after organ transplantation. The new microemulsion CsA formulation, Neoral, has been associated with a more reproducible absorption and a better patient outcome as compared to the old formulation Sandimmune. Recently, several generic CsA formulations have been tested as bioequiv...

No bioequivalence studies have been conducted for mesalamine because of differences in formulation. Based on U.S. Food and Drug Administration definitions for bioequivalence, none of these drugs can be classified as bioequivalent or therapeutically equivalent. No adequate comparative trials have been conducted with equivalent mesalamine doses to determine if any of the current formulations are ...

Formulators are charged with the responsibility to formulate a bioequivalent product (in case of ANDA) product which is physically and chemically stable, manufacturable at commercial scale. Different crystal structures in polymorphs arise when the drug substance crystallizes in different crystal packing arrangements and/or different conformations. Besides, Polymorphs cocrystallization is now im...

This paper raises some of the ethical issues involved in the recruitment of healthy volunteers (HVs) by clinical research organizations (CROs) for bioavailability and bioequivalent (BA/BE) studies. It also explores the underlying reasons for the participation of the HVs and their interaction with the CROs. The findings are based on the data collected from 50 HVs participating in a BA/BE study c...

Adherence to immunosuppression and minimizing variability in drug exposure are important considerations in preventing rejection and maximizing overall transplant outcomes. The availability of once-daily tacrolimus may confer potential benefit by simplifying immunosuppressive regimens, thereby improving medication adherence among transplant recipients. Pharmacokinetic studies in healthy normal v...

AIM To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. METHODS 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied. Blood samples were drawn up to 72 hours following drug administrations. Rosuvastatin plasma concentrations were determined by liquid chromatogr...

This double-blind crossover clinical trial randomized 12 adult males to receive 200 mg of caffeine from a green coffee extract, a guayusa leaf extract, and a synthetic control to compare their safety, absorption, and effect on neurotransmitters. The results showed no statistically significant changes in blood pressure or heart rate from baseline to 120 min postdose of each natural source compar...

The generic anticancer drugs are developed in the field of anticancer therapy and are commercially available. Generally, the safety and efficacy of a brand anticancer drug are determined by phase 1, 2 and 3 clinical trials. In contrast, clinical trials are not necessarily required by guidelines for the development of generic drugs and are usually not performed. Pharmacokinetic equivalence is co...

The pharmacokinetics and tissue distribution of two norfloxacin (NFLX) formulations, norfloxacin-glycine acetate (NFLXGA) and norfloxacin nicotinate (NFLXN), were compared after single oral administration with a dose of 5 mg equivalent NFLX base/kg of body weight in twenty rabbits. The pharmacokinetic characteristics of all formulations were fitted by a two-compartment open model. The eliminati...

NEW DRUG APPROVALS Adzenys XR-ODT for ADHD The FDA has given the green light to Adzenys XR-ODT (Neos Therapeutics) for the treatment of attention -deficit/ hyperactivity disorder (ADHD) in patients 6 years of age and older. With this approval, the product is the first extended-release orally disintegrating tablet (ODT) for this indication. Adzenys XR-ODT contains amphetamine loaded onto a mixtu...