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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…
Pharmaceutical Formulation, Process Development and Manufacturing of Products Focusing on Poorly Water Soluble Drugs
Extensive experience in formulation design and manufacturing process development and optimization gained working for large, medium and smaller companies.Having worked on the development of a relatively large number of small molecules at all stages of development, Expert has gained specialist…
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
Clinical Development, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…