Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy o...

PURPOSE Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real-world consistency of electronic labeling for bioequivalent drugs from different manufacturers. METHODS Using natural language processing, we indexed ...

A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand)...

BACKGROUND: Fentanyl buccal tablet (FBT; FENTORA(R), Cephalon, Inc., Frazer, PA, USA) is indicated in the US for breakthrough pain in patients with cancer who are already receiving and are tolerant to around-the-clock opioid therapy for underlying persistent cancer pain. For each individual patient, FBT should be titrated to the effective dose. OBJECTIVE: The primary objective was to characteri...

BACKGROUND Data availability in developing countries is known to be extremely varied and is one of the constraints for setting the national reference levels (RLs) for the REDD-plus (i.e. 'Policy approaches and positive incentives on issues relating to reducing emissions from deforestation and forest degradation in developing countries; and the role of conservation, sustainable management of for...

the bioavailability of two dipyridamol tablet formulations of (dipyridamole from tolidaru and persantin from boehringer) was compared in 14 healthy male volunteers who received a single dose of 25 mg of the test (t) and the reference (r) products in a randomized balanced 2-way crossover design. plasma samples were obtained over a 16 h interval and dipyridamole concentrations determined by hplc ...