Literature DB >> 19523010

Early human studies of investigational agents: dose or microdose?

Lionel D Lewis.   

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Year:  2009        PMID： 19523010      PMCID： PMC2675037          DOI： 10.1111/j.1365-2125.2009.03397.x

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


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  6 in total

1.  Risks in new drug development: approval success rates for investigational drugs.

Authors:  J A Dimasi
Journal:  Clin Pharmacol Ther       Date:  2001-05       Impact factor: 6.875

2.  The development of phase I cancer trial methodologies: the use of pharmacokinetic and pharmacodynamic end points sets the scene for phase 0 cancer clinical trials.

Authors:  A Hilary Calvert; Ruth Plummer
Journal:  Clin Cancer Res       Date:  2008-06-15       Impact factor: 12.531

3.  Reduction of dietary fat absorption by the novel gastrointestinal lipase inhibitor cetilistat in healthy volunteers.

Authors:  Andrew Bryson; Stephan de la Motte; Christopher Dunk
Journal:  Br J Clin Pharmacol       Date:  2008-09-19       Impact factor: 4.335

4.  The PARP inhibitor, ABT-888 potentiates temozolomide: correlation with drug levels and reduction in PARP activity in vivo.

Authors:  Joann P Palma; Luis E Rodriguez; Velitchka D Bontcheva-Diaz; Jennifer J Bouska; Gail Bukofzer; Milagros Colon-Lopez; Ran Guan; Kenneth Jarvis; Eric F Johnson; Vered Klinghofer; Xuesong Liu; Amanda Olson; Mary J Saltarelli; Yan Shi; Jason A Stavropoulos; Gui-Dong Zhu; Thomas D Penning; Yan Luo; Vincent L Giranda; Saul H Rosenberg; David J Frost; Cherrie K Donawho
Journal:  Anticancer Res       Date:  2008 Sep-Oct       Impact factor: 2.480

5.  Safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple doses of lecozotan in healthy young and elderly subjects.

Authors:  Alain Patat; Virginia Parks; Sangeeta Raje; Anna Plotka; Didier Chassard; F Le Coz
Journal:  Br J Clin Pharmacol       Date:  2009-03       Impact factor: 4.335

6.  A pharmacokinetic evaluation of five H(1) antagonists after an oral and intravenous microdose to human subjects.

Authors:  Ajay Madan; Zhihong O'Brien; Jianyun Wen; Chris O'Brien; Robert H Farber; Graham Beaton; Paul Crowe; Berend Oosterhuis; R Colin Garner; Graham Lappin; Haig P Bozigian
Journal:  Br J Clin Pharmacol       Date:  2009-03       Impact factor: 4.335
  6 in total
  4 in total

1.  A human microdose study of the antimalarial drug GSK3191607 in healthy volunteers.

Authors:  Malek Okour; Geo Derimanov; Rodger Barnett; Esther Fernandez; Santiago Ferrer; Stephanie Gresham; Mohammad Hossain; Francisco-Javier Gamo; Gavin Koh; Adrian Pereira; Katie Rolfe; Deborah Wong; Graeme Young; Harshad Rami; John Haselden
Journal:  Br J Clin Pharmacol       Date:  2017-12-29       Impact factor: 4.335

2.  Prediction of nonlinear intestinal absorption of CYP3A4 and P-glycoprotein substrates from their in vitro Km values.

Authors:  Tatsuhiko Tachibana; Motohiro Kato; Yuichi Sugiyama
Journal:  Pharm Res       Date:  2011-09-13       Impact factor: 4.200

3.  Human microdose evaluation of the novel EP1 receptor antagonist GSK269984A.

Authors:  Thor Ostenfeld; Claire Beaumont; Jonathan Bullman; Maria Beaumont; Phillip Jeffrey
Journal:  Br J Clin Pharmacol       Date:  2012-12       Impact factor: 4.335

Review 4.  Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development.

Authors:  T Burt; K Yoshida; G Lappin; L Vuong; C John; S N de Wildt; Y Sugiyama; M Rowland
Journal:  Clin Transl Sci       Date:  2016-03-30       Impact factor: 4.689
  4 in total

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