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Experts in Clinical Research
Anna Akinshina Elizabeth R. Dumont Alexander R. Gerson Dr. Sateesh B Arja Anita Airee Peter J. Embi N. Elagovan Shaun Grannis Dr. Patricia Rhynders Beulah Shekha Johanne Eliacin Bert van der Zwaan Frank Caligiuri Renae Chesnut Cheryl Clarke Andrew Miesner Dr. David Amor Thomas Felzmann Avihu Boneh John Carlin View MoreVirginia (Ginny) Schmith, Ph.D. FCP
Clinical Pharmacology and Pharmacometrics
NSF Bioensaios
Estonia
Dr. Schmith has 28 years of leadership and experience in Clinical Pharmacology and Pharmacometrics. Dr. Schmith provides expert consulting in clinical development and pharmacometric strategies for compounds from candidate selection through registration and beyond; development, implementation, and interpretation of strategies (e.g. protocols, analyses, reports, briefing documents, IND, NDA/MAAs) for pharmacokinetics/ pharmacodynamics and modeling and simulation, participating in regulatory meetings (including Advisory Committees), and evaluating the probability of successful differentiation from competitors. Her therapeutic area experience includes Anesthesia, Dermatology, CNS, Antiviral, Gastrointestinal, Cardiovascular, Hematology, Duchenne Muscular Dystrophy, Respiratory, and Inflammation. Dr. Schmith has worked on approximately 10+ NDAs/MAAs, 10+ INDs, 50+ PK/PD or Population PK/PD analyses.
Anesthesia, Dermatology, CNS, Antiviral, Gastrointestinal, Cardiovascular, Hematology