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Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…
Biotechnology: All Areas of Business and Technology
Expert has extensive hands-on experience with, and knowledge of, deoxyribonucleic acid (DNA) probe technology, having worked in this area for 10 years. He used nucleic acid probe technology to characterize mammalian viruses and oncogenes while performing research supported by the…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Immunology, Vaccine Research
Expert is an internationally recognized expert in mucosal immunology. He has published more than 70 papers and reviews in several prestigious scientific journals. He is best known for experimentally establishing (with continuing research) the concept of a common mucosal immunologic…
Statistical Analysis, Market Research, Clinical Trials,Marketing Mix Models,Pharmaceuticals,DOE
CLINICAL TRIAL: Expert has over 20 years experience in the statistical design and analysis of clinical trials of health care products. His experience includes working with both pharmaceutical and over-the-counter products. His recent analytical work has included preparing clinical trial…
Fluorescence Spectroscopy, Analysis of Metal Ions by Chelation with Organic Ligands, etc.
FLUORESCENCE SPECTROSCOPY. Expert has worked in the area of fluorescence spectroscopy for almost thirty years. He has published extensively on the influences of pH and solvent composition upon fluorescence spectra and has used these phenomena to study the rates and…
Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal…
Mass Spectrometry, HPLC/MS, Ion Trap MS, LC/MS/MS in Environmental, Food, Proteomic, and Pharmaceutical Analysis
Expert has been hired by law firms as an expert witness in the area of analytical chemistry. He has worked with 15 law firms in his career, with some of the cases going over multiple years. This experience includes: •…
Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization
Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…
High Purity Process Engineering
Expert specializes in providing independent technical services to critical process industries such as manufacturing of pharmaceutical products and other specialty chemicals where high levels of purity must be maintained. WATER-TREATMENT FILTRATION PROCESS; CONTAMINATION CONTROL. Expert provides support in process development,…