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Nutrition: Animal & Human; Mineral Bioavailability, Support to Nutritional Claims
His doctoral thesis pertained to the study of fatty acid synthesising enzymes in the different subcellular fractions of rabbit during the development of atherosclerosis and the effect of estrogens on them. The postdoctoral work at Rice University was on the…
Mineral Bioavailability, Calcium Metabolism, and Bone Health
Expert’s laboratory studies calcium metabolism during life stages of high demand, i.e., building peak bone mass during adolescence and bone loss in postmenopausal women. Calcium needs in adolescence is investigated with metabolic research camps (Camp Calcium). Dietary alternatives to estrogen…
Controlled Release, Microencapsulation, Drug delivery, Taste Masking, Bioavailability Enhancement
Expert has almost twenty years of experience in the formulation of pharmaceuticals for controlled release delivery. This work includes drug bioavailability enhancement, tastemasking, enteric protection, tableting, colonic delivery, prevention of ingredient interaction, nasal delivery, and buccal delivery. He has employed…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Formulation Chemistry
Spray drying expertise in volatile solvents and end-user food powder products. A lead formulation chemist with over eight years of experience in the area of the formulation. A talented chemist that excels in a high-performing multidisciplinary research environment in the…
Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Pharmaceutics
Excipients are broadly defined as any pharmacologically inert components other than the active pharmaceutical ingredient (API) that are added intentionally to the pharmaceutical formulations. Unintentional variability in the properties of the excipients may have a range of influences on their…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement
Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at…