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General Hematology/Oncology, Utilization/ Peer-Review, Medico-Legal, Program Develop/Administration
As an academic physician who has extensive experience in research, clinical medicine and administration, he is able to advise on various facets of anticancer drug development and therapy and cytotoxic drug therapy. As an academic physician who has extensive experience…
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
Toxicology, Cyanide, Toxic Metals, Environmental Health, Risk Assessment
Expert MD is a physician specializing in the evaluation and treatment of patients who have developed injuries or illness as a result of chemical, physical or biological agents. She is Board Certified in: Toxicology – through the American Board of…
Scientific Fraud; the Organization and Management of Business Operations
Expert has established a clear record of finding key management and organization problems in manufacturing, hospital operations and the research and development of DNA diagnostics. Since 1976, the expert has uncovered and addressed significant organization problems in small and large…
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…
Economic Damages and Lost Profits Calculations
Expert focuses on the calculation of economic damages. He prepares expert reports on lost earnings in personal injury, wrongful death, and employment matters, drafting expert reports, critiquing opposing experts and expert testimony in state and federal courts across the country.…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…
Pharmacoepidemiology, Pharmacoeconomics, Epidemiology, FDA, Drugs, Education
Expert is one of the leaders in the field of pharmacoepidemiology. He has extensive experience consulting on issues of applying epidemiological principles to the risk/benefit assessment of drugs. As Director of Global Pharmacoepidemiology and Health Economics Research for a major…