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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…
Polymer and Coatings R&D
Expert obtained his Ph.D in 1965. He possesses 37 years’ experience in supporting product R&D and problem-solving for the decorative/architectural, packaging, liquid industrial (wood, gelcoat, coil, ED, gen. metals) and powder coatings businesses. His experience therein is underpinned by his…
Pharmaceutical Formulation
Expert received his M.S. and doctorate in Pharmaceutical science from Long Island University, Brooklyn campus in 2017. During his doctoral dissertation, he worked on the rheological characterization of transdermal formulation and application of rheological models in product development and scale-up…
Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
Decontamination, Precision Cleaning, Ferrofluids, Nanoparticles, Process Design and Development
The behavior of colloidal particles (now nano particles) has been the focus of Expert's professional career, starting with his doctoral studies on the spontaneous agglomeration of fine powders in graduate school. While at AVCO Corporation, he did pioneering work in…
Drug Delivery, Formulation Development of NCE\’s, Pre-formulation, Stability, and 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 solids. For the…
Polymer Processing and Product Development (Films, Fibers, Nanofibers, Nanocomposites)
PROCESS/STRUCTURE/PROPERTY RELATIONSHIPS Expert has extensive experience and recognized accomplishments in process/structure/property relationships in polymers, especially processes involving polymer orientation and crystallization. Polymers in which he has primary experience include polyesters (PET, PEN, PBT, PTT, PLA), polyamides (PA6, PA66), and polyolefins…
Dry Bulk Powder Handling
He has been primarily involved in the use of various carbon blacks in pigmentation of plastics, fillers for electrical conductivity and reinforcement. This experience is in the processes of compounding, masterbatching, feeding and storage. Expert has been the primary designer…
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…