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drug evaluation




product evaluation


Drug Evaluation Experts

The following experts are available as drug evaluation consultants and drug evaluation expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Drug Evaluation - Any process by which efficacy, adverse reactions/side effects toxicity, metabolism, absorption, elimination, preferred route of administration, drug-drug interaction, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.

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Expert in 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 ... See full profile

California (CA), USA

Expert in Developmental and Reproductive Toxicology Study Design, Data Evaluation, and Report Review
Expert has acquired knowledge and expertise on birth defects in three ways: 1) teaching university courses on human embryology and on causes and manifestations of birth defects; 2) conducting lab animal research; and 3) ... See full profile

Alabama (AL), USA

Expert in 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, ... See full profile

Massachusetts (MA), USA

Expert in New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to ... See full profile

Arizona (AZ), USA

Expert in Drug Delivery, Formulation Development of NCE's, Preformulation, Stability, Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral ... See full profile

California (CA), USA

Expert in Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst, an editor ... See full profile

Virginia (VA), USA

Expert in Clinical Psychology, Personality and Neuropsychological Assessments, Research
Expert obtained her Doctorate degree in Psychological Medicine and Psychiatry from the University of London, UK. She is a Honorary Visiting Research Associate of the Institute of Psychiatry, King's College London and a Scientific Fellow ... See full profile



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