Sentences with phrase «safety and efficacy protocols»

Scientists poured scorn on the decision, contending it puts patients at risk and undermines the authority of the Brazilian Health Surveillance Agency (the equivalent of the U.S. Food and Drug Administration) to regulate research and approval of new drugs based on internationally accepted safety and efficacy protocols.

Not exact matches

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

The study protocol calls for the children to be monitored for 15 years in order to assess the treatment's safety and efficacy.

Several studies, like Dr. Daniel Bulluscio's study in 2009 have shown the safety and efficacy of HCG on weight loss during Dr Simeon's protocol.

This 3 - injection protocol is becoming the treatment of choice of many veterinarians regardless of stage of disease, due to its increased safety and efficacy.

We pride ourselves in utilizing some of the most scientifically advanced technology, combining the best available equipment with software like EclipseTM and Radialogica that enable our clinical teams to deliver treatment with precision, safety and efficacy while capturing information and continually optimizing delivery protocols.

3:00 p.m. Balancing Safety and Efficacy of Vaccine Protocols... Walking the Veterinary Tight Rope — Dr. Brian Dorcey, Zoetis

One - bottle combination vaccine for swine emphasizes efficacy, safety and convenience in either a one - or two - dose protocol

Study protocol for a randomised controlled double - blinded trial of the dose - dependent efficacy and safety of primaquine for clearance of gametocytes in children with uncomplicated falciparum malaria in Uganda