Intertek Scientific & Regulatory Staff: Hana Fikree

Hana Fikree, M.Sc., DABT Scientific and Regulatory Consultant I

Hana Fikree joined the Pharmaceutical & Healthcare Group at Intertek Scientific & Regulatory Consultancy (formerly Cantox) in 2007. Her primary focus is the preparation of literature-based toxicology/safety assessments for various compounds including, but not limited to, degradants, contaminants, impurities, excipients, and extractables/leachables. In this capacity, Ms. Fikree has successfully developed rationales to justify the derivation of specification limits or permitted daily exposure values for these compounds and has determined the risks to human health from the presence of impurities, degradants, and/or extractables/leachables in drug formulations or medical devices. Ms. Fikree also is involved in the critical review and interpretation of nonclinical and clinical study data as well as in the writing, preparation, and review of a variety of regulatory dossiers associated with product development. She continues to develop her special area of expertise in genotoxicity and serves as a vital resource and manager of projects related to this field.

Ms. Fikree received her B.Sc. with honours in Toxicology from the University of Toronto and completed her M.Sc. in Pharmacology and Toxicology at Queen's University. Her graduate thesis investigated the pulmonary biotransformation of cigarette smoke carcinogens and her research has been recognized in the form of scholarship awards from the Canadian Institutes of Health Research and the Canadian Cancer Society Research Institutes' Programme of Research in Environmental Etiology of Cancer. Ms. Fikree was board certified as a Diplomate of the American Board of Toxicology (DABT) in 2016 and is a member of the Society of Toxicology.


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