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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…
in vitro diagnostic assay designing, development and troubleshooting
Experthas developed and participated in assay development and troubleshooting for variety of target molecules with special skill in development of ELISA on different platforms (spectroscopy, luminescence and electrochemical). He has also acquired very good grasp on nanoparticles based rapid assays.…
Analytical Chemistry, HPLC, LC/MS, GC/MS, GC/MS/MS, Data analysis, method development, qPCR, Western Blotting
Areas of expertise: LC-MS/MS, GC-MSD/FID/ECD, GC-MS/MS, HPLC, Thermofisher QXactive, ABSCIEX Triple quadrupoles, Agilent Triple quadrupoles, Agilent GC/MS, Shimadzu HPLC/UHPLC systems, Analytical method development and validation for extraction, identification and quantitation of small molecules, Data analysis, Team management and training, Project…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
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.…
Organic and Medicinal Chemistry
Expert has expertise and broad knowledge in Synthetic Organic Chemistry of various classes of compounds coupled with experiences and adept characterizing compounds using various NMR techniques 1-D and 2-D (COSY, HMBC, TOCSY, ROESY) diverse analytic techniques for compounds purification, use…
Adhesives, Polymer Nanocomposites, Plastics, Biomaterials
Expert wrote his Ph.D. research in the area of thermosetting composite and rubbery materials. After graduation he began work with National Starch and Chemical Company in specialty pressure-sensitive adhesives and moved then to Integra Life Sciences in collagen-based regenerative biomaterials.…
Biochemistry, Inorganic, Analytical, Organic Chemistry, Protein Chemistry, Gadolinium, Imaging Agent
Expert has worked in the fields of bioinorganic, bioorganic, and biophysical chemistry for the past 30 years. Expert runs a large research group at the Employer, in the Department of Chemistry, and mentors graduate students, postdocs, and undergraduates in many…
Analytical Chemistry: HPLC, LC-MS, Bioanalysis. R&D projectmanagement; writing of publications
Expert’s scientific expertise includes the development, optimization and validation of quantitative bioanalytical methods for small molecules, peptides and biopharmaceutical drugs as well as for their metabolites in biological fluids (plasma, urine, tissue, etc.). These methods are essential for the pharma…
Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, Ph.D., is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device…