Isadore
Kanfer

Drug Development & Disease Diagnostics

Toronto ON
Canada

Isadore Kanfer is a Professor (Status) at the Leslie Dan Faculty of Pharmacy, and in addition to this role, he is Emeritus Professor of Pharmaceutics at Rhodes University in South Africa. His research interests are dermatological and topical drug products, safety and efficacy.

Dr. Kanfer was appointed to the Chair as the first Professor of Pharmaceutics at Rhodes University, South Africa in 1980 and served as Head of Pharmacy and Dean of the Faculty from 1987-1989 and from 1999-2007. He was appointed by the South African Minister of Health as a member of the South African Medicines Control Council (MCC) and served as Chair of the Pharmaceutical/Bioequivalence and Complementary Medicines committees. He was a Visiting Professor of Pharmacy at the University of California, San Francisco in 1980/81 and then in 1990 spent a year as Visiting Professor at the University of North Carolina’s School of Pharmacy in Chapel Hill, in the USA. Prof. Kanfer spent several years in the Pharmaceutical Industry in Canada as Vice-President: Scientific Affairs. In 2012, he was appointed as a Member of Health Canada’s Scientific Advisory Committee on Pharmaceutical Sciences & Clinical Pharmacology (SAC-PSCP) and has served as Chair of the American Association of Pharmaceutical Scientists (AAPS) Bioequivalence Focus Group. He is a Founder Member and Past Chairman of the South African Academy of Pharmaceutical Sciences, an inaugural committee member (Secretary) of CSPS and is Associate Editor of the Journal of Pharmacy & Pharmaceutical Sciences and Editor-in Chief of the Encyclopedia of Pharmaceutical Science and Technology. Professor Kanfer was the recipient of the Rhodes University Vice Chancellor’s Distinguished Senior Research award in 2007. He is an honorary life member of the South African Academy of Pharmaceutical Sciences and a Fellow of the South African Pharmaceutical Society. He was elected as an AAPS Fellow in 2010 and in 2013 as Fellow of the Canadian Society for Pharmaceutical Sciences (CSPS). He was awarded the CSPS Lifetime Achievement Award in 2023.

Dr. Kanfer has supervised numerous postgraduate students and post-doctoral fellows and contributed to over 200 research publications including 23 book chapters, numerous invited speaking engagements and 3 radio interviews. He has also served as editor and co-editor of 6 books in the series, Generic Drug Product Development and is the editor of an AAPS/Springer book in the AAPS Advances in the Pharmaceutical Sciences Series entitled "Bioequivalence Requirements in Various Global Jurisdictions? and is presently preparing a second edition of this book.

One of the main objectives of the 1st edition of the book, Bioequivalence Requirements in Various Global Jurisdictions, was to combine and collate bioequivalence standards from across the world into a single reference source with the specific intent to facilitate future harmonization of country specific standards and to provide food for thought that standardization should ultimately result in a high priority objective to facilitate a harmonized international process. A further important objective was to gather the various bioequivalence requirements used in different global jurisdictions to provide a single source of such relevant information in the quest to harmonize regulatory requirements. He has over 40 years’ experience with the FDA’s human vasoconstrictor assay (VCA) for topical corticosteroid products and is currently focusing on the development of new methods for the bioequivalence assessment of other topical dermatological dosage forms where the drug is not intended to be absorbed into the systemic circulation.

Area of Research Description

Bioequivalence assessment of topical dosage forms intended for local action using the following research methodologies:

  • Dermatopharmacokinetics
  • Vasoconstrictor assay (VCA) for topical corticosteroids
  • Microdialysis
  • Open flow microdiffusion
  • In-vitro methodology

Research Challenge

Assessment of bioequivalence of topical dosage forms not intended to be absorbed into the systemic circulation.

Proposed Solution

Using the following research techniques and methodology:

  • Dermatopharmacokinetics (tape stripping method)
  • Vasoconstrictor Assay (VCA) to asses the bioequivalence of topical corticosteroid dosage forms

Selected Publications

A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5%. Katrin I. Tiffner, Isadore Kanfer, Thomas Augustina, Reingard Ramla, Sam G. Raney, Frank Sinner. Int.J.Pharm.,535(1-2):217-227, (Jan 2018)

Application of an Optimized Tape Stripping Method for the Bioequivalence Assessment of Topical Acyclovir Creams. Sumalatha Nallagundla, Srinivas Patnala, Isadore Kanfer. AAPS Pharm SciTech,19(4): 1567-1573, 2018.

Identification of Mechanism and Pathway of the Interaction between the African Traditional Medicine, Sutherlandia Frutescens, and the Antiretroviral Protease Inhibitor, Atazanavir, in Human Subjects Using Population Pharmacokinetic (PK) Analysis. A.C. Müller, M. P. Ducharme and I.Kanfer. J Pharm Pharm Sci (www.cspsCanada.org) 21(1s), 215s – 221s, 2018

Revisiting FDA’s 1995 Guidance on Bioequivalence Establishment of Topical Dermatologic Corticosteroids: New Research Based Recommendations. Deniz Ozdin, Naveen Sharma, Jorge Lujan-Zilbermann, Philippe Colucci, Isadore Kanfer, Murray P. Ducharme. J Pharm Pharm Sci (www.cspsCanada.org) 21, 413 - 428, 2018

Novel Approach for the Bioequivalence Assessment of Topical Cream Formulations: Model-Based Analysis of Tape Stripping Data Correctly Concludes BE and BIE. Deniz Ozdin, Isadore Kanfer, Murray P. Ducharme. Pharm Res 37, 20 (2020).

In vitro release testing (IVRT) of topical hydrocortisone acetate creams: A novel approach using positive and negative controls. Nyengeterai Amanda Mudyahoto, Seeprarani Rath, Ashmita Ramanah and Isadore Kanfer. Dissolution Technologies, Volume 27, Issue 1, February 2020   

A Validated IVRT Method to Assess Topical Creams Containing Metronidazole Using a Novel Approach. Seeprarani Rath and Isadore Kanfer. Pharmaceutics 2020, 12(2), 119.

Assessment of “Sameness” and/or Differences between Marketed Creams Containing Miconazole Nitrate Using a Discriminatory in vitro Release Testing (IVRT) Method. Potiwa Purazi, Seeprarani Rath , Ashmita Ramanah, and Isadore Kanfer. Sci. Pharm. 2020, 88, 6; 1-13.

Publications

ORCID


Keywords: tape stripping, vasoconstrictor assay, microdialysis, openflow microdiffusion