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Developmental and Reproductive Toxicology Study Design, Data Evaluation, and Report Review
Expert (prefers “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) extensive technical consulting and…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Fats and Oils: Chemistry, Health, and Nutrition
Since the early 1980s, Expert has been very active in the edible oils area. For eight years, he served as Chairman of the Biological Subcommittee of the Institute of Shortening and Edible Oils (ISEO), a trade association of refiners of…
Clinical Chemistry, Laboratory Diagnostics, Immunoassay Development, Therapeutic Drug Monitoring
Expert has extensive experience in the field of clinical chemistry and clinical diagnostics. Development of analytical methods for trace analytes in biological fluids, especially in the field of clinical diagnostics, has been Expert's main job responsibility and success over the…
Toxicology (Benzene, Solvents, Metals); Medical Science and Microbiology (Causation); Environmental (Risk Assessment)
Expert has the Ph.D. in Microbiology with 30+ years of research and teaching experience with appointments in Molecular Microbiology and Immunology, School of Medicine; the Biomedical Sciences Department, and as Adjunct Professor of Pathology, College of Veterinary Medicine; and as…
Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology
Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…