Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug Development

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development ◽

10.1201/b10279-19 ◽

2010 ◽

pp. 18-1-18-14

Author(s):

Richard Simon

Keyword(s):

Clinical Trials ◽

Drug Development ◽

Predictive Biomarker ◽

New Drug ◽

New Drug Development

General Principles and Considerations in Multiregional Clinical Trials for Simultaneous Global New Drug Development

Multiregional Clinical Trials for Simultaneous Global New Drug Development ◽

10.1201/b20090-8 ◽

2016 ◽

pp. 37-52

Keyword(s):

Clinical Trials ◽

Drug Development ◽

New Drug ◽

New Drug Development

A Progress Report on Cooperative Working Groups for Improving Efficiency of Clinical Trials for New Drug Development (Chiken)

Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics ◽

10.3999/jscpt.46.127 ◽

2015 ◽

Vol 46 (3) ◽

pp. 127-132

Author(s):

Mariko TANIGUCHI ◽

Masayoshi NAKABAYASHI ◽

Ichiro OSHIBA ◽

Satoshi SUGIHARA ◽

Shuhei NOBUTANI ◽

...

Keyword(s):

Clinical Trials ◽

Drug Development ◽

Progress Report ◽

New Drug ◽

Working Groups ◽

New Drug Development

Clinical Trials in New Drug Development

Journal of Clinical Hypertension ◽

10.1111/jch.12085 ◽

2013 ◽

Vol 15 (5) ◽

pp. 306-309 ◽

Cited By ~ 6

Author(s):

J. Rick. Turner ◽

Theo J. Hoofwijk

Keyword(s):

Clinical Trials ◽

Drug Development ◽

New Drug ◽

New Drug Development

Multiregional Clinical Trials for Simultaneous Global New Drug Development

10.1201/b20090 ◽

2016 ◽

Cited By ~ 5

Keyword(s):

Clinical Trials ◽

Drug Development ◽

New Drug ◽

New Drug Development

The View of the EORTC New Drug Development Office on PET in (Pre)Clinical Trials of Anticancer Drugs

PET for Drug Development and Evaluation ◽

10.1007/978-94-011-0429-6_25 ◽

1995 ◽

pp. 267-275

Author(s):

H. R. Hendriks ◽

J. Wanders

Keyword(s):

Clinical Trials ◽

Drug Development ◽

Anticancer Drugs ◽

New Drug ◽

New Drug Development

Clinical Trials in New Drug Development

xPharm: The Comprehensive Pharmacology Reference ◽

10.1016/b978-008055232-3.60251-x ◽

2007 ◽

pp. 1-5

Author(s):

Melissa L. Goodhead ◽

Albert J. Azzaro

Keyword(s):

Clinical Trials ◽

Drug Development ◽

New Drug ◽

New Drug Development

Exploratory evaluation of a commercially available Japanese medical record database as an external control for comparative clinical trials in new drug development: Amyotrophic lateral sclerosis

Neurology and Clinical Neuroscience ◽

10.1111/ncn3.12198 ◽

2018 ◽

Vol 6 (4) ◽

pp. 94-99 ◽

Cited By ~ 1

Author(s):

Saeko Fukamachi ◽

Masayuki Hashiguchi ◽

Kunihiko Takahashi ◽

Mayumi Mochizuki

Keyword(s):

Clinical Trials ◽

Amyotrophic Lateral Sclerosis ◽

Drug Development ◽

Medical Record ◽

External Control ◽

New Drug ◽

New Drug Development ◽

Lateral Sclerosis ◽

Medical Record Database

Phase 0 clinical trials in oncology new drug development

Perspectives in Clinical Research ◽

10.4103/2229-3485.76285 ◽

2011 ◽

Vol 2 (1) ◽

pp. 13 ◽

Cited By ~ 9

Author(s):

UmeshChandra Gupta ◽

Sandeep Bhatia ◽

Amit Garg ◽

Amit Sharma ◽

Vaibhav Choudhary

Keyword(s):

Clinical Trials ◽

Drug Development ◽

New Drug ◽

Phase 0 ◽

New Drug Development

Clinical Trials for New Drug Development: Optimal Investment and Application

Manufacturing & Service Operations Management ◽

10.1287/msom.2017.0616 ◽

2017 ◽

Vol 19 (3) ◽

pp. 437-452 ◽

Cited By ~ 9

Author(s):

Panos Kouvelis ◽

Joseph Milner ◽

Zhili Tian

Keyword(s):

Clinical Trials ◽

Drug Development ◽

Optimal Investment ◽

New Drug ◽

New Drug Development

Review on “Multiregional clinical trials for simultaneous global new drug development”

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.412 ◽

2016 ◽

Vol 100 (5) ◽

pp. 412-412

Author(s):

Rominder “Romi” Singh

Keyword(s):

Clinical Trials ◽

Drug Development ◽

New Drug ◽

New Drug Development