For type 2 diabetes mellitus treatment and clinical development, proper evaluation of cardiovascular risk has been required by regulatory agencies (eg, the US Food and Drug Administration) since cardiovascular safety is very important in this patient population. The US Food and Drug Administration issued general guidelines for cardiovascular safety evaluation that outlined the requirements cons...

Background The management of drug safety with the collection of reliable safety data during the conduction of clinical trials conduct is essential for the registry and marketing of products. The systematic evaluation of this process, based on objective measures, requires the application of quality instruments. This study was aimed to design and validate eight instruments through the components ...

background and objectives: pharmacovigilance is central to the control of the menace of adverse drugs reactions. despite the fact that development of policy and practice framework to improve patients’ safety partly rely on availability of authentic data on pharmacovigilance activities, knowledge about pharmacovigilance activities among healthcare professionals in nigeria is limited. to help fil...

Phage endolysins have received increasing attention as potent antibacterial agents. However, although safety evaluation is a prerequisite for the drug development process, a good laboratory practice (GLP)-compliant safety evaluation has not been reported for phage endolysins. A safety evaluation of intravenously administered SAL200 (containing phage endolysin SAL-1) was conducted according to G...

Yun-Jeong Seok, Jae-Young Her, Yong-Gun Kim, Min Yeop Kim, Soo Young Jeong, Mina K. Kim, Jee-yeon Lee, Cho-il Kim, Hae-Jung Yoon and Kwang-Geun Lee Department of Food Science and Biotechnology, Dongguk University, Goyang-si, Korea Nutrition Policy & Promotion Team, Korea Health Industry Development Institute, Chungcheongbuk-do, Korea Bureau of Health Industry Promotion, Korea Health Industry De...

responding to ruth mcdonald’s editorial on the rise of leadership and leadership development programmes in healthcare, this paper offers three arguments. firstly, care is needed in evaluating impact of leadership development, since achievement of organisational goals is not necessarily an appropriate measure of good leadership. secondly, the proliferation of styles of leadership might be unders...