Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development high income settings. Over last decade, this model has implemented LMICs with aim of accelerating next generation vaccines that would perform better these However, most LMICs, ethics and regulatory framework conduct are not place. In Zambia, yet to be conducted thus we stakeholder enga...

Glimepiride/metformin(2/500mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin(2/500mg) fixed-dose combination(FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerabi...

This article focuses on patient-reported outcomes (PROs) and their role in decision making patient-centred healthcare. Let»s look at how PRO can be used clinical trials, to evaluate the effectiveness of treatment, validate a claim product label by regulatory authorities, practice monitor patient conditions.

Tedizolid, a novel oxazolidinone antibacterial with potent activity against a wide range of Gram-positive pathogens, was recently approved by regulatory authorities for the treatment of acute bacterial skin and skin structure infections. A commercial broth microdilution device (Sensititre; Thermo Fisher Scientific) was validated using 285 selected Gram-positive isolates, and the device was docu...

A wave of regulatory reform is now transforming the U.S. electricity industry. As state and federal authorities allow independent power producers to compete with utilities in supplying electricity, consumers are paying close attention to the effects of this change on their energy bills. Although deregulation poses significant structural challenges, the introduction of competitive pressures shou...

The PLATO trial revealed a remarkable advantage of ticagrelor over clopidogrel in ACS patients. Unless the regulatory authorities discover serious flaws with the study, which is unlikely, the drug may substantially change the present landscape of oral antiplatelet therapy, especially in high-risk patients. Despite a somewhat unfavourable safety profile, ticagrelor has a lot of room to compensat...