|
Clinical Trials & Bionalytical
Bioavailability/ Bioequivalence Studies
Full GCP and regulations compliance BA/BE studies are developed with a tight control, meeting your product development timetable to reduce time-to-market. All support is given to assure your expectations and regulatory demands, until the final approval by authorities. All regulatory aspects, like study submission and notification duties could be performed by our services.
Pharmacokinetics and Statistics Consultancy Study Design Development CRF development Statistical Plan Development Pharmacokinetic Analysis / Statistical Analysis SAS Code Programming Protocol and Report writing Based on sound study design, detailed product information, and our cumulative research experience, full regulatory complaint a study protocols are developed for your study. At the end of the study an integrated study report is delivered including all Clinical, Analytical and Statistical raw data and results prepared in conformity of the requirements of the ICH, FDA, and EMEA. LEF Clinical facilities are located at two sites. One in Lisbon (Portugal) and another in Sao Paulo state (Brazil) housing a total of 200 beds. The focus of bioanalysis is to provide a quantitative measure of active drug and/or its metabolite(s). Samples may be derived from any biological matrices (plasma, serum, urine, tissues etc). Installed capacity for the quantification of drugs in biological samples follows a high troughput of samples in a OECD-GLP compliant environment. Analytical techniques such as LC-MS/MS; GC-MS, LC-UV are first choice for reliable results. Protocol writing, validation procedures and reporting meets current EMEA and FDA regulatory requirements. Several methodologies have been developed in order to assists BA/BE studies and determination of residual veterinary drugs in animal tissues as you can consult at Validated methods(not limited to). |