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Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, Rudd DJ, Li CC, Magee M, Mukherjee A, Nagao L, Purohit VS, Roy A, Salem AH, Sinha V, Suleiman AA, Taskar KS, Upreti VV, Weber B, Cook J. Galluppi GR, et al. Among authors: purohit vs. Clin Pharmacol Ther. 2021 Nov;110(5):1172-1175. doi: 10.1002/cpt.2265. Epub 2021 May 15. Clin Pharmacol Ther. 2021. PMID: 33991429 Free PMC article. Review. No abstract available.
FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".
Akbar M, Berry-Bibee E, Blithe DL, Day RS, Edelman A, Höchel J, Jamshidi R, Kim MJ, Li L, Purohit VS, Turpin JA, Scott PE, Strauss DG, Sun H, Tepper NK, Zhang L, Yu C. Akbar M, et al. Among authors: purohit vs. J Clin Pharmacol. 2018 Dec;58(12):1655-1665. doi: 10.1002/jcph.1285. Epub 2018 Aug 24. J Clin Pharmacol. 2018. PMID: 30144093 Free PMC article.
Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019.
Khong YM, Liu J, Cook J, Purohit V, Thompson K, Mehrotra S, Cheung SYA, Hay JL, Fletcher EP, Wang J, Sachs HC, Zhu H, Siddiqui A, Cunningham L, Selen A. Khong YM, et al. Eur J Pharm Biopharm. 2021 Jul;164:66-74. doi: 10.1016/j.ejpb.2021.04.010. Epub 2021 Apr 18. Eur J Pharm Biopharm. 2021. PMID: 33878434
Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.
Polli JE, Cook JA, Davit BM, Dickinson PA, Argenti D, Barbour N, García-Arieta A, Geoffroy JM, Hartauer K, Li S, Mitra A, Muller FX, Purohit V, Sanchez-Felix M, Skoug JW, Tang K. Polli JE, et al. AAPS J. 2012 Sep;14(3):627-38. doi: 10.1208/s12248-012-9376-z. Epub 2012 Jun 9. AAPS J. 2012. PMID: 22684402 Free PMC article.
Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1).
Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. Schlessinger J, et al. Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6. Am J Clin Dermatol. 2020. PMID: 32212104 Free PMC article. Clinical Trial.
Crisaborole and atopic dermatitis skin biomarkers: An intrapatient randomized trial.
Bissonnette R, Pavel AB, Diaz A, Werth JL, Zang C, Vranic I, Purohit VS, Zielinski MA, Vlahos B, Estrada YD, Saint-Cyr Proulx E, Ports WC, Guttman-Yassky E. Bissonnette R, et al. Among authors: purohit vs. J Allergy Clin Immunol. 2019 Nov;144(5):1274-1289. doi: 10.1016/j.jaci.2019.06.047. Epub 2019 Aug 13. J Allergy Clin Immunol. 2019. PMID: 31419544 Free article. Clinical Trial.
36 results