Vadodara
5 hours ago
27 Applied
JOB ID:163780
Job Type
Returnee Program
Functional Area
Pharmacist/Bio-Technologist
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
8 - 12 Yrs
Key Skills Required
pk and statistical analysis, in-vitro parameters, ivivc, simulation and pharmacokinetic modelling
Other Skills Required
Job Description
· Education : M.Pharm
· Experience : 8 -12 years
· Department : Pharmacokinetics
1. Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products(injectable, Semisolids, TDS etc.) towards different regulatory submission.
2. Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols
3. Developing protocol for patient based PK end point & also for PD/Clinical end point BE studies for complex generics.
4. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.
5. Coordinate with the CRO in India and outside India for finalizing bio study pilot and pivotal study protocol for DCGI BE application.
6. Preparation of pharmacokinetic queries response, scientific justification for study design/ protocol/ results towards various regulatory agencies for their concurrence or advice.
7. Having in-depth understanding of in-vitro parameters and identification
... See More· Education : M.Pharm
· Experience : 8 -12 years
· Department : Pharmacokinetics
1. Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products(injectable, Semisolids, TDS etc.) towards different regulatory submission.
2. Review of BA/BE study protocol and provide Pharmacokinetic (PK) inputs into the study protocols
3. Developing protocol for patient based PK end point & also for PD/Clinical end point BE studies for complex generics.
4. Perform PK and Statistical analysis of in-vivo data obtained from BA/BE and pharmacokinetics studies using Phoenix Software.
5. Coordinate with the CRO in India and outside India for finalizing bio study pilot and pivotal study protocol for DCGI BE application.
6. Preparation of pharmacokinetic queries response, scientific justification for study design/ protocol/ results towards various regulatory agencies for their concurrence or advice.
7. Having in-depth understanding of in-vitro parameters and identification of critical variables impacting the in-vivo release. Perform IVIVC, simulation and Pharmacokinetic modelling to improve BE success. See Less
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
