LEF ensures phase I clinical trial for formulation bioequivalence testing, particularly BA/BE assessment, in accordance with GCP compliance, respecting all phases of developed product and 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 (National and European authorities).
All regulatory issues, like study submission and notification duties, are handled by us.
- Clinical trials and Bioavailability and Bioequivalence studies (200 beds available);
- In vitro-In vivo Correlations (IVIVC);
- Study Design Development;
- CRF development;
- Clinical Trial Monitoring;
- Pharmacocinectic Analysis;
- Statistical Analysis – SAS Code Programming;
- Protocol and Report writing.
LEF has experience in the development and validation of pharmaceutical quantification methods and/or of its metabolites in several types of biological matrices like plasma, serum, urine and biological tissues.
Pharmaceutical quantification in biological matrices is performed in accordance with OECD-GLP requirements. Our available analytical techniques include LC-MS/MS, GC-MS and HPLC-UV.
Several methods were developed and validated in different biological matrices, with the purpose of analytes quantification in human biological samples, as well as in animal tissue residues.