Combining "Bottom-up" and "Top-down" Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics.

Autor: Lu T; Department of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA., Fraczkiewicz G; Simulations Plus Inc, Lancaster, California, USA., Salphati L; Department of Drug Metabolism and Pharmacokinetics, Genentech Inc, South San Francisco, California, USA., Budha N; Department of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA., Dalziel G; Department of Small Molecule Pharmaceutical Sciences, Genentech Inc, South San Francisco, California, USA., Smelick GS; Department of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA., Morrissey KM; Department of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA., Davis JD; Department of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA., Jin JY; Department of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA., Ware JA; Department of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2017 Nov; Vol. 6 (11), pp. 747-755. Date of Electronic Publication: 2017 Oct 17.

Impact of food and the proton pump inhibitor rabeprazole on the pharmacokinetics of GDC-0941 in healthy volunteers: bench to bedside investigation of pH-dependent solubility.

Autor: Ware JA; Small Molecule Clinical Pharmacology, ‡Small Molecule Pharmaceutical Sciences, §Drug Metabolism and Pharmacokinetics, ∥Clinical Project Management, and ⊥Early Clinical Development, Genentech Research and Early Development , 1 DNA Way, South San Francisco, California 94080, United States., Dalziel G, Jin JY, Pellett JD, Smelick GS, West DA, Salphati L, Ding X, Sutton R, Fridyland J, Dresser MJ, Morrisson G, Holden SN

Publikováno v: Molecular pharmaceutics [Mol Pharm] 2013 Nov 04; Vol. 10 (11), pp. 4074-81. Date of Electronic Publication: 2013 Oct 24.

Assessment of granulation technologies for an API with poor physical properties.

Autor: Dalziel G; Small Molecule Pharmaceutical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. dalziel.gena@gene.com, Nauka E, Zhang F, Kothari S, Xie M

Publikováno v: Drug development and industrial pharmacy [Drug Dev Ind Pharm] 2013 Jul; Vol. 39 (7), pp. 985-95. Date of Electronic Publication: 2012 Jun 02.

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A randomized, cross‐over trial of metoprolol succinate formulations to evaluate PK and PD end points for therapeutic equivalence.

Autor: Mosley, Scott A.^1,2 (AUTHOR), Kim, Sarah³ (AUTHOR), El Rouby, Nihal^1,4 (AUTHOR), Lingineni, Karthik³ (AUTHOR), Esteban, Valvanera Vozmediano³ (AUTHOR), Gong, Yan¹ (AUTHOR), Chen, Yiqing¹ (AUTHOR), Estores, David⁵ (AUTHOR), Feng, Kairui⁶ (AUTHOR), Kim, Hyewon⁶ (AUTHOR), Kinjo, Minori⁶ (AUTHOR), Langaee, Taimour¹ (AUTHOR), Li, Zhichuan⁶ (AUTHOR), Schmidt, Siegfried O. F.⁷ (AUTHOR), Johnson, Julie A.¹ (AUTHOR), Frye, Reginald F.¹ (AUTHOR), Fang, Lanyan⁶ (AUTHOR), Zhao, Liang⁶ (AUTHOR), Binkley, Philip F.⁸ (AUTHOR), Schmidt, Stephan³ (AUTHOR)

Publikováno v: CTS: Clinical & Translational Science. Jul2022, Vol. 15 Issue 7, p1764-1775. 12p.