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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…
Enzyme Assay, Analytical chemistry, Protein purification
Enthusiastic, resourceful and innovative Scientist and Academician, offering over 18 years of well-honed research and teaching experience, with knowledge across the field of Chemical Biology, Biotechnology and Analytical science. Research focuses on chemical techniques to the study of biological systems…
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.…
Polymer chemistry, Organic chemistry, Analytical chemistry
Qualifications in brief: Industrial experience in Emulsion Polymerization and solution polymerizations: Product & applications development, scale-up, and customer service; Organic synthesis & Scale-up; Taught senior level polymer chemistry and organic chemistry courses; Ph.D. in Organic chemistry. • Organic and polymer…
Chemistry
Expert is a chemist with expertise in the total synthesis of carbohydrates and pheromones, formation of micro/nanocapsules for controlled delivery, synthesis and modification of macromolecules and radio-labeled compounds, ultra-sensitive measurements in petroleum products, biological fluids, and food, coupling and decoupling…
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…
Drug Delivery Technologies;Therapeutic Polymers; Biomaterials
Expert is the Principal and Consultant at a consulting company. The company provides advisory and consultancy services in the areas of drug discovery, therapeutic polymers and biomaterials. He has extensive experience in these areas and co-invented eight therapeutic polymers to…
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, Drug Delivery, Tissue Engineering, and Regenerative Medicine
Expert is an internationally recognized expert in biomaterials development, drug delivery (e.g., protein, plasmid DNA, etc), tissue engineering, and regenerative medicine. Expert, PhD, received his B.S.E. in Mechanical Engineering and Material Science and Biomedical Engineering, cum laude, from Duke University…