Ziyaur Rahman

Education and Training

• Hamdard University, Bachelor of Science in Pharmacy, 2000
• Hamdard University, New Delhi, India, Master of Science in Pharmaceutics, 2002
• Hamdard University, New Delhi, India, PhD in Pharmaceutics, 2005
• University of Mississippi, Postdoctoral Research Associate, School of Pharmacy, 2007-2008
• CDER, FDA, Maryland, USA, ORISE Fellow, Division of Product Quality Research, 2008-2011

Research Interests

• Formulation and process design of traditional (tablet, capsule, gel, emulsion, ointment etc) and complex dosage forms (microparticles, implant, pediatric, nanosuspension, nanoemulsion etc.);
• Drug product quality and process understanding through Quality by Design (QbD) and Process Analytical Technologies (PAT) approaches;
• Development of in vitro release performance tests for traditional and complex dosage forms
• Evaluation of in-vitro bioequivalence for complex dosage forms
• Design and evaluation of abuse-deterrent/meth-deterrent formulations
• 3-dimensional printers’ application in pharmaceuticals printing
• Continuous manufacturing of pharmaceutical dosage forms
• Application of non-destructive methods (Raman, FTIR, XRPD, ssNMR, NIR, NIR-Chemical imaging) for quantification of components of formulations
• Multivariate analysis (chemometrics, PCR, PLSR, DFA etc.) in pharmaceutics

Teaching Interests

• Process and product development
• Industrial and physical pharmacy
• Pharmaceutics compounding
• Pharmaceutical calculation
• Controlled and targeted drug delivery
• Chemometric and big-data management

Awards, Recognition and Service

• FDA liaison to USP Expert Committee on Excipients, 2015-2016.
• Member of ‘Immediate Release/Modified Release Work Group’, Office of Pharmaceutical Quality, FDA, 2015
• FDA grant reviewer, 2014-2016
• Editorial board member of International Journal of Pharmaceutical Investigation, American Journal of Analytical chemistry, Current Nanoscience and Scientia Pharmaceutica
• Reviewer for more than a dozen peer reviewed journals
• FDA ‘Team Excellence’ award for ‘The development of a new in-vitro dissolution method to demonstrate bioequivalence of vancomycin hydrochloride to allow submission to ANDAs’ in 2010
• ‘Teaching Team’ award of the year 2012 for ‘Electrolyte, Acid-Bases and Nutrition’ course (IPT: PHAR 710). Texas A&M Health Science Center
• FDA ‘Team Excellence’ award for ‘Cyclosporine Ophthalmic Research, in 2014
• FDA ‘Regulatory Science Excellence’ award for ‘Chemometric Methods for Tacrolimus Crystallinity Team’ for the quantification of crystallinity and discriminatory dissolution methods development for the tacrolimus products’, in 2014
• FDA ‘Team Excellence’ award for ‘The extraordinary contributions to the review and management of post approval changes to ANDAs’ in 2014.
• FDA ‘Certificate of Appreciation’ for serving distinguished CDER faculty 2014-2015.
• FDA ‘Regulatory Science Excellence’ award for ‘Developing a performance matrix for equivalence evaluation of cyclosporine ophthalmic emulsions, paving the pathway for generic approval and provided scientific support to address sponsor’s CP request’ in 2015.
• FDA ‘Team Excellence’ award for ‘Understanding the root cause of warfarin sodium product quality, development of discriminatory dissolution method and chemometric models for warfarin sodium fraction quantification’ in 2015
• FDA ‘Special Recognition’ award for ‘The outstanding first review of generic abuse-deterrent formulations through a pilot review-research team approach’ in 2015
• FDA ‘Special Recognition’ award for ‘Outstanding research effort on Abuse Deterrent Formulations and for the first review of generic ADF through a pilot Review-Research team approach’ in 2016
• FDA ‘Team Excellence’ award for ‘Development of in-vitro quality metrics of acyclovir ointment and cream for the review of NDA # 20408 and Zovirax ANDAs’ in 2016
• 'FDA group recognition’ award for ‘Crystalline quantification in new tacrolimus extended release product for regulatory action’ in 2016
• FDA ‘Regulatory Science Excellence’ award for ‘Quantification of crystalline fraction of warfarin sodium in the drug products and in-use stability of commercial products’ in 2016
• 'FDA Leveraging Collaboration’ award for ‘Outstanding research effort on cyclosporine ophthalmic emulsion and for the precedent setting review of generics through a pilot review-research approach’ in 2016