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European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences|August 8, 2024
Relevance of distinctions and parallels between the US and EU guidelines for determination of comparative effectiveness and safety of the orally inhaled drug productsGur Jai Pal SinghMolecular Pharmaceutics|April 7, 2025
Regulatory and Scientific Complexities in Application of the Proposed Prior Approval Supplement Pathway for Substitution of the Low Global Warming Potential Propellants in the Marketed Metered Dose InhalersGur Jai Pal SinghJournal of Aerosol Medicine and Pulmonary Drug Delivery|December 9, 2024
Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory ConsiderationsGur Jai Pal Singh, S Prasad PeriMolecular Pharmaceutics|August 12, 2024
Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum DoseGur Jai Pal Singh, Anthony J HickeyJournal of Pharmaceutical Sciences|November 10, 2006
Conference report: Bio-International 2005Kamal K Midha, Vinod P Shah, Gur Jai Pal Singh, et al.Clinical Pharmacokinetics|March 15, 2017
Scientific Rationale for Determining the Bioequivalence of Inhaled DrugsOmar S Usmani, Mathieu Molimard, Vaibhav Gaur, et al.AAPS Pharmscitech|April 6, 2007
Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols: part 2--evaluation of a method for determining equivalenceDavid Christopher, Wallace P Adams, Douglas S Lee, et al.AAPS Pharmscitech|April 6, 2007
Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: background for a statistical methodWallace P Adams, David Christopher, Douglas S Lee, et al.The Journal of Allergy and Clinical Immunology|November 6, 2002
A methacholine challenge dose-response study for development of a pharmacodynamic bioequivalence methodology for albuterol metered- dose inhalersPeter S Creticos, Wallace P Adams, Brent G Petty, et al.Journal of Aerosol Medicine and Pulmonary Drug Delivery|April 8, 2025
Inhalable and Nasal Biologics: Analytical, Formulation, Development, and Regulatory ConsiderationsDavid Cipolla, Christopher J Gruenloh, Nani Kadrichu, et al.Pageof 2