Journal of Bioequivalence & Bioavailability

Journal of Bioequivalence & Bioavailability
Open Access

ISSN: 0975-0851

+44 7480022449



Researcher, Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)


August 2013 – May 2018         Ph.D. in Pharmaceutics, School of Pharmacy, University of Connecticut
July 2008 – June 2010         M.S. Pharm in Pharmaceutical Sciences, NIPER, Mohali
August 2004 – June 2008     B. Pharm in Pharmaceutical Sciences, Gujarat University

May 2018 – present – ORISE Fellow, Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)
? Science Reviewer in Office of Generic Drugs/Division of Therapeutic Performance/CDER/FDA
? Preparation of product specific guidance for generic drug products (ANDA)
? Perform comprehensive Q1/Q2/Q3 review (focusing on comparative IVRT and BE studies between ANDA and RLD)
? Preparation of responses to controlled correspondence from ANDA (provide critical information on requirements for filing ANDA)
? Preparation of responses to control request (identification and evaluation of deficiencies in the ANDA package)

EXECUTIVE SUMMARY ? Formulation process development, optimization, scale-up and pre-validation process and product characterization of dosage forms (small molecules and biologics)
? Expertise in formulation development of solid orals, amorphous and crystalline nanoparticles of poorly soluble drugs, oral peptides formulations (spray dried and freeze dried micro/nanoparticles), liposomes (continuous and batch manufacturing), steriles (parenterals) and semisolid formulations
? Expertise in analytical method development, validation and troubleshooting for: RP-HPLC; UPLC; LC-MS; PXRD; DSC; TGA; FTIR; PLM; Karl Fisher; Zetasizer; TA.HD plus; TA.XT plus; TA ARES G2; USP apparatus I and; II
? Strong proficiency of manufacturing tools: spray dryer; lyophilizer; wet media milling; microfluidizer; high pressure homogenizer; high shear mixer; ultrasonicator and; unguator mixer
? Recipient of 2016 International Pharmaceutical Excipients Council award – AAPS annual meeting
? Pharmaceutical industrial experience ~ 3 years

Research Interest

Formulation development of muco- and bio-adhesive micro/nano-particles for oral delivery of peptides (Strong experience in analytical instruments method development and validation (UPLC and LCMS), solid state tools, oral peptide release and adhesion studies (in vitro, ex vivo and in vivo testing))

Other Research Interests:

1) Formulation design and evaluation of Amorphous and Crystalline Nanoparticles of BCS class II and II/IV drugs 
2) Non-clinical modeling and risk assessment of FDA-regulated Drug-Nanocrystals 
3) Quality by design approach to understand preparation and stabilization of Amorphous Nanoparticles 
4) Continuous manufacturing of Liposomal drug formulations: materials understanding and process control 
5) Evaluation and Development of Dissolution Testing Methods for Semisolid Ocular Drug Products 
6) Identification and validation of biomarkers for meals, exercise and stress to automate artificial pancreas systems