Sentence examples for authorization study from inspiring English sources

Multicenter, prospective, two-armed, post authorization study over 9 months in 14,200 patients with uncontrolled hypertension with and without the metabolic syndrome (doctors' diagnosis based on the Adult Treatment Panel III criteria 2001).

It was therefore the aim of the present analysis of the post authorization study Treat to Target to investigate in more detail the influence of the PPARγ activating ARB Irbesartan with or without HCTZ on metabolic parameters.

Post-marketing authorization studies can allow regulatory bodies and pharmaceutical industries to detect safety signals; however, their ability to draw inferences against comparators is very limited because of the heterogeneity of patients included.

This is a prospective, observational, multinational European post-authorization study among adults treated with onabotulinumtoxinA for CM headache prophylaxis.

Post-authorization study 17 public health centers, Primary Care Health Service of Madrid Spainn).

By including such an aspect, our study became a post-authorization study with medication, although all treatments offered are licensed drugs, according the legislation of the Community of Madrid, with a longstanding experience.

The study was classified by the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios) as a Non-Interventional (Observational) Post-Authorization Study, and the protocol was approved by the Parc de Salut Mar Clinical Research Ethics Committee in Barcelona.

The study protocol was first classified as a Post-Authorization Study – Other Designs (PAS-OD) by the Spanish Agency for Medicines and Medical Devices and, secondly, was reviewed and approved by the Independent Ethics Committee of Hospital Germans Trias i Pujol de Badalona, Barcelona.

In July , 2002 observational post-authorization studies were subjected to regulation in Spain, giving rise to an uproar among sponsors and investigators.

Pregnant women are generally not included in pre-authorization studies, thus the risk benefit profile of medicines used in pregnancy is assessed mostly through post-authorization studies.

The study was conducted in accordance with the international ethics recommendations and according to the Spanish post-authorization studies legislation.