The aim of the evaluation was to establish bioequivalence between two oral 3.0 g sachet forms of L-ornithine-L-aspartate (LOLA). It was designed as randomised, two-way crossover study with a 1-week washout interval. Blood samples were collected throughout a 12 h period after administration of reference and test product to 12 fasting healthy male volunteers. Plasma were analyzed by sensitive, re...

• Innovator drugs are given their own brand name and a common generic name that is shared with products certified as bioequivalent by a regulatory authority. • Characteristics—including names—that uniquely identify a seller’s product are entitled to legal protection against misappropriation. • Well-controlled studies and decades of use reveal that generic drugs approved by the Food and Drug Adm...

BACKGROUND The purpose of this study was to determine whether a non-sonographer clinician (NSC) could obtain ultrasound images of the carotid artery, measure carotid intima-media thickness (CIMT), and identify findings indicating increased cardiovascular risk in an office setting. METHODS Eight NSCs from five sites were trained to use a handheld ultrasound device to screen the carotid arterie...

The Ministry of Health is constantly emphasizing the quality, efficacy and safety of pharmaceutical products to safeguard the Malaysians public1. The Drug Control Authority at its 92nd meeting has decided to review the registration of generic products to include bioequivelent studies requirement for certain categories of oral immediate release products2 Bioavailability testing of drug products ...

succinate) was the first triptan medication to target the nerves and blood vessels believed to trigger a total migraine (including throbbing pain, nausea, and sensitivity to light and sound, with or without aura). The first triptan to receive Food and Drug Administration (FDA) approval for the acute treatment of migraines in adults, IMITREX has treated more than 750 million migraines in the pas...

Results The mean AUC(0,12 h) was higher following application of TDS ® -testosterone (61.8 ng ml − 1 h), compared with Androgel ® (57.7 ng ml − 1 h) and TDS ® -placebo (50.7 ng ml − 1 h. The mean C max (0,12 h) was similar for TDS ® -testosterone (6.6 ng ml −1 ) and Androgel ® (6.5 ng ml − 1 ) and these values were higher than those for TDS ® -placebo (5.7 ng ml − 1 ). Analysis of variance show...

The problem of rising prescription drug costs has emerged as a critical policy issue around the world, particularly in the United States. These costs strain the budgets of patients and health insurers, and directly contribute to adverse health outcomes by reducing adherence to important medications. Drug spending is driven by brand-name drugs, which currently account for about 20% of all prescr...

Comparing modified-release formulations can be difficult using current bioequivalence criteria. Two 60-mg-once-daily nifedipine formulations are deemed bioequivalent in Canada. This study examined the validity of the assumption that these interchangeable, but different, delivery technologies are therapeutically equivalent in maintaining systolic blood pressure (SBP) control throughout the entir...

Literature data on the properties of chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride related to the Biopharmaceutics Classification System (BCS) are reviewed. The available information indicates that these chloroquine salts can be classified as highly soluble and highly permeable, i.e., BCS class I. The qualitative composition of immediate release (IR) tablets containi...

The present invention relates to multiple-unit tablet dosage forms, which is composed of several subunits (multiparticulates/pellets). Each small multiparticulate further composed of many layers. Some layer contains drug substance; others are rate controlling polymer. The resulting multiple-unit tablet dosage forms of pantoprazole were satisfactory fabricated. Pelletization technique has some a...