- Conducting extensive literature search related to Pharmacokinetic parameters, BA/BE studies.
- Evaluation of development projects with respect to physicochemical properties and pharmacokinetic properties and its impact on BA/BE studies.
- Preparation of design strategy and decision tree regarding dissolution media selection note for formulation development.
- Identification of bio-relevant in-vitro dissolution media and test conditions based on physicochemical characteristics and pharmacokinetics of the drug molecule and supporting the formulation development team in developing bioequivalent formulations.
- Conducting In-vitro In-vivo correlations/relations (IVIVC/IVIVR).
- Development of sound scientific strategies to investigate any BA/BE failures and provide inputs to the respective cross functional teams.
- Preparation, review and finalization of Pilot and Pivotal bio study protocols.
- Review of Pilot and Pivotal bio study reports.
- Perform statistical calculations on the in-vivo data (BE data) and extrapolation of data to find suitable number of subjects required for BE studies and designing BE studies accordingly.
- Coordinate with the CROs for conducting pilot/Pivotal biostudies and tracking the studies progress and outcome.
- Preparation of SOPs related CPPK/Biopharmaceutics team.
ESSENTIAL EXPERIENCE, SKILLS AND ABILITIES:
- Sound knowledge on pharmacokinetics ADME.
- Deep understanding on In-vitro in-vivo correlations.
- Knowledge on Bio-relevant dissolution, FaSIF, SIF, SGF, FeSIF media etc.
- Knowledge on BA/BE/PKPD studies.
Salary: INR 4,50,000 - 7,50,000 PA.
Must have Key Skills
Other Key Skills
PG:M.Pharma - Any Specialization
Doctorate:Ph.D - Any Specialization
SYRI Research Pvt. Ltd.
SyriMed previously known as Thame Laboratories Licensed Medicines Division is one of the leading Pharmaceutical Companies in the UK specialising in the development, licensing, manufacture and marketing of liquid medicines.
Established during 2004 in Ruislip, West London; SyriMed with the experience from the development and manufacture of unlicensed medicines started in 2014 to obtain marketing authorisations for its unlicensed liquid medicines. In May 2020, SyriMed held over 50 marketing authorisations for liquid medicines within the UK.
SyriMeds success stems from its vibrant and productive Research and Development Department which develops and manufactures formulations for licensed medicines . All of SyriMeds formulations for which it holds marketing authorisations have been developed by SyriMeds own scientists.
SyriMed manufactures licensed medicines in its own facilities that meet the quality requirements of EU Good Manufacturing Practice (GMP).
Our in-house laboratories test the medicines manufactured to ensure they meet the strict requirements set by regulatory authorities.