Praveen Balimane
Senior Staff Fellow, Clinical Pharmacology at FDA
- Role
- Senior Staff Fellow, Clinical Pharmacology at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Praveen Balimane
Expert in Clinical Pharmacology and Drug Development Strategies (PreIND, Phase 1-3, post-marketing)- Well versed in Emerging Areas of Translational Science- Deep Experience in Regulatory Guidance in Overall Drug Development- Seasoned DMPK Expert in Drug Discovery
Experience
Senior Staff Fellow, Clinical Pharmacology
Jan 2013 — Present
Expertise in clinical pharmacology and clinical development strategies spanning first-in-human, Phase1, Phase 2, Phase 3, and Phase 4 (post-approval/marketing)· Proficient in role of PK/PD concepts, dose-response and concentration-response (both efficacy and safety) in drug development· Well-versed in emerging areas of translational science in drug development: Biomarkers in early drug development and patient stratification, pharmacogenomics in drug interactions, PBPK modeling and systems pharmacology· Expertise in translational science of predicting clinical outcomes based on experimental studies (in vitro, in vivo and clinical)· Clinical pharmacology reviewer trained to provide regulatory guidance to sponsors (Pharma, Research etc.) on overall development strategies, PMC’s, PMR’s, labels etc.· Exposed to drug development tools and softwares- JMP, SAS, NonMem, Phoenix, Kinetica etc.·
Education
Rutgers University, College of Pharmacy
Ph.D, Pharmaceutical Sciences
Birla Institute of Technology and Sciences (B.I.T.S)
Bachelor of Pharmacy (Honors) and M.S
Skills
- Adme
- Clinical Development
- Dmpk
- Drug Delivery
- Drug Development
- Drug Discovery
- Drug Metabolism
- Ind
- In Vivo
- Lifesciences
- Pharmaceutical Industry
- Pharmacokinetics
- Pharmacology
- Clinical Pharmacology
- In Vitro
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.