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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…
Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis
CORE SKILLS Instrumentation skills. APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl.…
Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…
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…
Biobased Materials, Silica and Sol-Gel Chemistry, Green and Sustainable Chemistry
He is an expert in all aspects of silica and sol-gel chemistry. His expertise includes silica films and coatings, silica insulators, fumed silica, spherical silica, silica supports, silica coatings for ceramics, silica in polymer composites and also hybrid silica organic…
Pharmaceuticals, Drug Delivery, OTC, and Rx products
Expert actively consults in nearly all routes of drug delivery, including oral, transdermal, topical, inhalation, injection/infusion, nasal, buccal and others. He holds a Ph.D in Polymer Science and Engineering, as well as an MS on the same topic. He holds…
Medicine and Biotech Materials, Polymers, Nanoparticles, Peptide and Protein Chemistry
Expert has a MSc in chemical engineering and a PhD in pure and applied biochemistry. Her PhD thesis was on enzyme technology (enzymatic synthesis) and molecular imprinting (preparation of chiral liquid chromatography stationary phases). Expert carried out postdoctoral studies in…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Biomaterials, Intraocular Lens Implants, DNA Analysis
Expert has completed doctoral studies in developing a novel polymer for intraocular lens implants. During this study she has designed several new experimental methods to detect polymer biocompatibility and toxicity to ocular and other cell types. Expert also has extensive…
Analysis, FEA, CFD, Medical Devices, Heat Transfer, Elastomers, Diffusion, Solar, Coupled Systems
Real invention and innovation most often springs from cross-fertilization and analogies from broad experience, quite apart from an entire career in a narrow field. See, for instance, Holyak and Thagard, "Mental Leaps: Analogy in Creative Thought". Expert is a broad…