Ch. Mihaela Cristina BRANESCU
Chemist PhD in Analytical Chemistry
University of Bucharest,
Chemistry Faculty, Bucharest
▪Thesis entitled “Evaluation of stability and backconversion in validation of bioanalytical methods” addresses a topical issue in a controversial and extensively discussed field regarding the development and validation of bioanalytical methods underlying bioavailability and / or bioequivalence studies of active substances in different pharmaceutical formulations. Background in both medicinal drug products research (for human and veterinary use) and clinical trials area.
1. Drug products research(for human and veterinary use):
Responsable for all the activities related to the conduct of pharmaceutical research of medicinal products) in compliance with applicable regulatory standards and procedures.
Providing scientific support for the Research and Development Department, for the Quality Control Department and for the Quality Assurance Department; Validation of analytical methods by using HPLC with DAD detection, dosage of the active compounds and detection of impurities. Sample preparation by using separations techniques such as: extraction, precipitation; dissolution tests, UV analysis. Preparing and processing of samples in accordance with SOPs and stated by requirements imposed for a GMP lab; Pharmaceutical product development – Early phase clinical trials (according to GCP requirements) – Bioequivalence/bioavailability studies Separation and identification of active compounds in the presence of other chemicals (in a complex mixture) by using sensitive high performance liquid chromatography HPLC coupled with mass spectrometry for fast and mass directed purification; 2. Clinical trials area Experience in the conduct and supervising of clinical research projects related to the development of medicines; Experience in supervising and conducting of audit schedule in the clinical research area by meaning of preparing required documentation and active participation to audits. Other: Publications: national and international Experience in implementing/developing the National/EU research projects.