Pharmaceutical Drug Stability Expert: ICH Compliance, Photochemistry, Photostability, Environmental Chemistry

Expertise

• Pharmaceutical drug stability testing. In depth knowledge of ICH guidelines and requirements for compliance.
• Photostability of pharmaceutical drugs. Photoprotection and stabilization of pharmaceutical drugs and sunscreens. Chemical actinometry. Solar simulation. Spectroradiometry.
• Aqueous-phase photochemistry. Identification and quantification of free radical oxidants and singlet molecular oxygen using spectroscopic techniques.
• Instrumental methods for identification and quantification of ground and surface water contaminants associated with hydraulic fracturing (fracking).
• Measurement of thermodynamic Henry's law constants (H) for partitioning of organic compounds between air and water.
• Theory and practice of chemical separations including: gas chromatography (GC), high performance liquid chromatography (HPLC), supercritical fluid chromatography (SFC), thin layer chromatography (TLC), ion chromatography (IC), size-exclusion chromatography (SEC), extraction, distillation, filtration, and centrifugation.

Experience

Independent Consultant, 2010 - Present

• Pharmaceutical drug patent litigation, pharmaceutical drug photostability testing.
• Improved strategies for pharmaceutical drug and sunscreen photostabilization, construction of solar simulators, impacts upon ground water quality from hydraulic fracturing (fracking), development of simple tests for fracking compounds in ground and surface waters, and trace organic analysis for pesticides and herbicides in environmental samples.

Indiana State University, Department of Chemistry, Associate Professor, 1996 - Present

• Taught undergraduate and graduate courses in chemistry.
• Set up a research laboratory and conducted research in pharmaceutical drug photochemistry and photostability, developed new methods for measurement of thermodynamic Henry's law constants, measured formation of reactive oxidants in illuminated aqueous solutions, assessed importance of photochemical reactions in surface waters contaminated with acid mine drainage.

Colorado State University, Department of Chemistry, Instructor, 2004 - 2006

• Taught freshman chemistry courses during summer sessions.

Indiana University - Purdue University Indianapolis, Instructor, 1996 - 1997

• For the School of Public and Environmental Affairs, taught a graduate level course in environmental chemistry.

Duke University, Environmental Chemistry Laboratory, Research Assistant, 1987 1991

• Measured the formation and steady-state concentrations of photochemically produced oxidant species such as hydroxyl radical (.OH) and other oxygen centered radicals as well as singlet molecular oxygen (1O2) and hydrogen peroxide in illuminated cloud and fog samples.
• Measured kinetic rate constants for reactions of oxidants and organic compounds in aqueous solutions.

Teaching Assistant

• Assisted in the instruction of graduate students in environmental chemistry and fate of organic chemicals courses.
• Instructed senior chemistry undergraduate students in instrumental methods of laboratory analysis.

Research Triangle Institute, North Carolina, Analytical Chemist, 1985 1987

• Responsible for management of a contract with the USEPA that involved the development of a repository of compressed gas cylinders that were used as analytical standards for testing the ability of hazardous waste
• incinerator facilities to monitor emissions.
• Developed automated cryogenic trapping method for gas chromatographic analysis of organics in air.

Virginia Commonwealth University, Chemistry and Physics, Teaching Assistant, 1983 1985

• Instructed students in general chemistry recitation, general chemistry laboratory, university physics laboratory, and synthetic inorganic chemistry laboratory.
• Responsible for synthesis and characterization of supported metal catalysts used for production of hydrocarbons from synthesis gas. Developed analytical methodology for complex hydrocarbon mixtures.
• Synthesized organic compounds used as starting materials for polymeric adhesives for use in attaching heat shield tiles to the National Aeronautics and Space Administration (NASA) space shuttle.

Pesticide Residue Laboratory, Richmond, Virginia, Analytical Chemist, 1982 1983

• Responsible for analysis of pesticide, herbicide and other pollutant residues in soil, water, tissue, and foodstuffs using GC, HPLC, and IC.
• Extensive experience with extraction and cleanup of of tissue samples and foodstuffs. Monitored kepone levels in fish from the James River.

Research Proposals

• Photostabilities of Sunscreen Active Ingredients
• Photochemistry of Several New Sunscreen Active Ingredients
• Direct Detection of Singlet Molecular Oxygen in Photobiological Systems
• Remediation of Power Plant Effluent Water Contaminated with Selenium and Cyanide
• Development of a Chemical Actinometer for Pharmaceutical Photostability Studies
• HP-5880A Gas Chromatograph Enhancement
• Photostability of Several Structurally Related Chemical Compounds Having Potential Application as New Sunscreen Active Ingredients
• Aqueous-Phase Photochemistry of Atmospheric Hydrocarbon Oxidation Products