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A population pharmacokinetic and pharmacodynamic modelling approach to support the clinical development of RBP-6000, a new, subcutaneously injectable, long-acting, sustained-release formulation of buprenorphine, for the treatment of opioid dependence.
Nasser AF, Heidbreder C, Gomeni R, Fudala PJ, Zheng B, Greenwald MK. Nasser AF, et al. Among authors: fudala pj. Clin Pharmacokinet. 2014 Sep;53(9):813-24. doi: 10.1007/s40262-014-0155-0. Clin Pharmacokinet. 2014. PMID: 25015174 Clinical Trial.
Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis.
Andorn AC, Haight BR, Shinde S, Fudala PJ, Zhao Y, Heidbreder C, Learned SM, Fox NL, Nadipelli VR, Hassman D, Rutrick D. Andorn AC, et al. Among authors: fudala pj. J Clin Psychopharmacol. 2020 May/Jun;40(3):231-239. doi: 10.1097/JCP.0000000000001195. J Clin Psychopharmacol. 2020. PMID: 32282418 Free PMC article. Clinical Trial.
Population pharmacokinetics and prediction of dopamine D2 receptor occupancy after multiple doses of RBP-7000, a new sustained-release formulation of risperidone, in schizophrenia patients on stable oral risperidone treatment.
Laffont CM, Gomeni R, Zheng B, Heidbreder C, Fudala PJ, Nasser AF. Laffont CM, et al. Among authors: fudala pj. Clin Pharmacokinet. 2014 Jun;53(6):533-43. doi: 10.1007/s40262-014-0132-7. Clin Pharmacokinet. 2014. PMID: 24464285 Clinical Trial.
Liquid chromatography/tandem mass spectrometry method for simultaneous determination of cocaine and its metabolite (-)ecgonine methyl ester in human acidified stabilized plasma samples.
Liu Y, Zheng B, Strafford S, Orugunty R, Sullivan M, Gus J, Heidbreder C, Fudala PJ, Nasser A. Liu Y, et al. Among authors: fudala pj. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Jun 15;961:77-85. doi: 10.1016/j.jchromb.2014.04.052. Epub 2014 May 4. J Chromatogr B Analyt Technol Biomed Life Sci. 2014. PMID: 24861875 Clinical Trial.
Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
Haight BR, Learned SM, Laffont CM, Fudala PJ, Zhao Y, Garofalo AS, Greenwald MK, Nadipelli VR, Ling W, Heidbreder C; RB-US-13-0001 Study Investigators. Haight BR, et al. Among authors: fudala pj. Lancet. 2019 Feb 23;393(10173):778-790. doi: 10.1016/S0140-6736(18)32259-1. Epub 2019 Feb 18. Lancet. 2019. PMID: 30792007 Clinical Trial.
Efficacy, Safety, and Tolerability of RBP-7000 Once-Monthly Risperidone for the Treatment of Acute Schizophrenia: An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study.
Nasser AF, Henderson DC, Fava M, Fudala PJ, Twumasi-Ankrah P, Kouassi A, Heidbreder C. Nasser AF, et al. Among authors: fudala pj. J Clin Psychopharmacol. 2016 Apr;36(2):130-40. doi: 10.1097/JCP.0000000000000479. J Clin Psychopharmacol. 2016. PMID: 26862829 Clinical Trial.
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