Professional Profile
Dr. Amy Mihalchik is a board-certified toxicologist with a Regulatory Affairs Certification (R.A.C.) from the Regulatory Affairs Professionals Society with expertise in human health risk assessment. Her work primarily focuses on integrating quantitative structure activity relationship (QSAR) model data, read-across analyses, and other weight-of-evidence approaches to support the safety of substances, including drug degradants, cosmetics, consumer product ingredients, and industrial chemicals. Dr. Mihalchik is experienced in interpreting QSAR output from numerous platforms commercially and freely available, including Lhasa DEREK, Leadscope Model Applier, VEGA, EPA T.E.S.T., and ToxTree, among others, and has contributed to working groups assessing the potential for using in silico tools to support drug degradant safety and carcinogenicity hazard assessments.
She also integrates results from literature-based risk assessments with client-generated data, regulatory agency documents, and corporate technical reports to address complex exposure and toxicity issues. To support workplace safety in the pharmaceutical manufacturing arena, Dr. Mihalchik derives occupational exposure limits (OELs) and acceptable daily intakes (ADIs) and develops permissible daily exposure limits (PDEs) and tolerable exposure values (TEs) for pharmaceutical compounds and devices, respectively. She also has expertise analyzing data from leachables and extractables, testing of medical devices, including familiarity with ISO guidelines, and ISO-10993 biocompatibility assessments of medical devices.
Her doctoral research at the National Institute for Occupational Safety and Health (NIOSH) focused on addressing potential toxicities associated with multi-walled carbon nanotubes using in vitro methods to support “safety by design” efforts.
Dr. Mihalchik is familiar with the body of regulatory documents issued by the FDA, ICH, ISO, and other entities, and she maintains current knowledge of toxicology and regulatory science through extensive commitment to continuing education courses, webinars/seminars, and active participation in professional societies. She has published multiple peer-reviewed book chapters and scientific articles, and has presented at scientific conferences since 2014.