Warning: Undefined array key "mm" in /www/wwwroot/www.ai-bt.com/si.php on line 10 Deprecated: trim(): Passing null to parameter #1 ($string) of type string is deprecated in /www/wwwroot/www.ai-bt.com/si.php on line 10 Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

× No keyword cloud information.

19 in total

1. Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival.

Authors: Paul Morgan; Piet H Van Der Graaf; John Arrowsmith; Doug E Feltner; Kira S Drummond; Craig D Wegner; Steve D A Street
Journal: Drug Discov Today Date: 2011-12-29 Impact factor: 7.851

2. International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice.

Authors:
Journal: Fed Regist Date: 2005-10-20

Review 3. Establishing risk of human experimentation with drugs: lessons from TGN1412.

Authors: M J H Kenter; A F Cohen
Journal: Lancet Date: 2006-10-14 Impact factor: 79.321

4. The TeGenero incident and the Duff Report conclusions: a series of unfortunate events or an avoidable event?

Authors: Christopher J Horvath; Mark N Milton
Journal: Toxicol Pathol Date: 2009-02-24 Impact factor: 1.902

Review 5. The use of biomarkers in human pharmacology (Phase I) studies.

Authors: A F Cohen; J Burggraaf; J M A van Gerven; M Moerland; G J Groeneveld
Journal: Annu Rev Pharmacol Toxicol Date: 2014-10-06 Impact factor: 13.820

6. Fatty acid amide hydrolase inhibitors display broad selectivity and inhibit multiple carboxylesterases as off-targets.

Authors: Di Zhang; Anita Saraf; Teodozyi Kolasa; Pramila Bhatia; Guo Zhu Zheng; Meena Patel; Greg S Lannoye; Paul Richardson; Andrew Stewart; John C Rogers; Jorge D Brioni; Carol S Surowy
Journal: Neuropharmacology Date: 2007-01-09 Impact factor: 5.250

7. Open letter on access to the BIA 10-2474 clinical trial data.

Authors: Kim Brøsen; Christian Funck-Brentano; Heyo K Kroemer; Munir Pirmohamed; Matthias Schwab
Journal: Lancet Date: 2016-12-10 Impact factor: 79.321

8. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

Authors: Joop van Gerven; Milton Bonelli
Journal: Br J Clin Pharmacol Date: 2018-05-30 Impact factor: 4.335

9. Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase.

Authors: Anne Kerbrat; Jean-Christophe Ferré; Pierre Fillatre; Thomas Ronzière; Stéphane Vannier; Béatrice Carsin-Nicol; Sylvain Lavoué; Marc Vérin; Jean-Yves Gauvrit; Yves Le Tulzo; Gilles Edan
Journal: N Engl J Med Date: 2016-11-03 Impact factor: 91.245

10. Effective visualization of integrated knowledge and data to enable informed decisions in drug development and translational medicine.

Authors: Lena Brynne; Anders Bresell; Niclas Sjögren
Journal: J Transl Med Date: 2013-10-08 Impact factor: 5.531

51 in total

Review 1. Applications of human pharmacokinetic prediction in first-in-human dose estimation.

Authors: Peng Zou; Yanke Yu; Nan Zheng; Yongsheng Yang; Hayley J Paholak; Lawrence X Yu; Duxin Sun
Journal: AAPS J Date: 2012-03-10 Impact factor: 4.009

Review 2. Prediction of exposure-response relationships to support first-in-human study design.

Authors: John P Gibbs
Journal: AAPS J Date: 2010-10-22 Impact factor: 4.009

3. The pharmaceutical industry needs more clinical pharmacologists.

Authors: Richard Peck
Journal: Br J Clin Pharmacol Date: 2017-08-16 Impact factor: 4.335

4. Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP.

Authors: Adam Cohen; Sergio Bonini
Journal: Br J Clin Pharmacol Date: 2018-05-30 Impact factor: 4.335

Review 5. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).

Authors: David R Jones; James W McBlane; Graham McNaughton; Nishanthan Rajakumaraswamy; Kirsty Wydenbach
Journal: Br J Clin Pharmacol Date: 2013-08 Impact factor: 4.335

6. Pharmacological vs. classical approaches in the design of first in man clinical drug trials.

Authors: Cornelis A van den Bogert; Adam F Cohen; Hubert G M Leufkens; Joop M A van Gerven
Journal: Br J Clin Pharmacol Date: 2017-10-06 Impact factor: 4.335

7. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.