Literature DB >> 19246571

The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development.

Mark N Milton1, Christopher J Horvath.   

Abstract

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Year:  2009        PMID： 19246571     DOI： 10.1177/0192623309332997

Source DB:  PubMed          Journal:  Toxicol Pathol        ISSN： 0192-6233            Impact factor:   1.902


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  6 in total

1.  Choice of Starting Dose for Biopharmaceuticals in First-in-Human Phase I Cancer Clinical Trials.

Authors:  Aaron R Hansen; Natalie Cook; M Stacey Ricci; Albiruni Razak; Christophe Le Tourneau; Kathleen McKeever; Lorin Roskos; Rakesh Dixit; Lillian L Siu; Mary Jane Hinrichs
Journal:  Oncologist       Date:  2015-05-11

2.  Implications of the BIA-102474-101 study for review of first-into-human clinical trials.

Authors:  Michael Eddleston; Adam F Cohen; David J Webb
Journal:  Br J Clin Pharmacol       Date:  2016-04       Impact factor: 4.335

3.  Impact of crystal polymorphism on the systemic bioavailability of rifaximin, an antibiotic acting locally in the gastrointestinal tract, in healthy volunteers.

Authors:  Corrado Blandizzi; Giuseppe Claudio Viscomi; Carmelo Scarpignato
Journal:  Drug Des Devel Ther       Date:  2014-12-16       Impact factor: 4.162

Review 4.  Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013.

Authors:  Hoon Young Suh; Carl C Peck; Kyung-Sang Yu; Howard Lee
Journal:  Drug Des Devel Ther       Date:  2016-12-08       Impact factor: 4.162

5.  Pharmacokinetic/pharmacodynamic modeling for dose selection for the first-in-human trial of the activated Factor XII inhibitor garadacimab (CSL312).

Authors:  Dipti Pawaskar; Xi Chen; Fiona Glassman; Frauke May; Anthony Roberts; Mark Biondo; Andrew McKenzie; Marc W Nolte; William J Jusko; Michael Tortorici
Journal:  Clin Transl Sci       Date:  2021-12-08       Impact factor: 4.689

Review 6.  Challenges and approaches for the development of safer immunomodulatory biologics.

Authors:  Jean G Sathish; Swaminathan Sethu; Marie-Christine Bielsky; Lolke de Haan; Neil S French; Karthik Govindappa; James Green; Christopher E M Griffiths; Stephen Holgate; David Jones; Ian Kimber; Jonathan Moggs; Dean J Naisbitt; Munir Pirmohamed; Gabriele Reichmann; Jennifer Sims; Meena Subramanyam; Marque D Todd; Jan Willem Van Der Laan; Richard J Weaver; B Kevin Park
Journal:  Nat Rev Drug Discov       Date:  2013-04       Impact factor: 112.288
  6 in total

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