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Literature DB >> 29381216

Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects.

Abstract

Keywords: Phase I; clinical trials; drug development, animal models; statistics and study design, methodology; toxicity; toxicology

Mesh：

Substances：
Drugs, Investigational

Year: 2018 PMID： 29381216 PMCID： PMC6005609 DOI： 10.1111/bcp.13529

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

× No keyword cloud information.

9 in total

1. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999.

Authors: James Cross; Howard Lee; Agnes Westelinck; Julie Nelson; Charles Grudzinskas; Carl Peck
Journal: Pharmacoepidemiol Drug Saf Date: 2002-09 Impact factor: 2.890

Review 2. Developing drug prototypes: pharmacology replaces safety and tolerability?

Authors: Adam F Cohen
Journal: Nat Rev Drug Discov Date: 2010-09-17 Impact factor: 84.694

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

Review 4. To scale or not to scale: the principles of dose extrapolation.

Authors: Vijay Sharma; John H McNeill
Journal: Br J Pharmacol Date: 2009-06-05 Impact factor: 8.739

5. The return of the prodigal son and the extraordinary development route of antibody TGN1412 - lessons for drug development and clinical pharmacology.

Authors: Marcel J H Kenter; Adam F Cohen
Journal: Br J Clin Pharmacol Date: 2015-04 Impact factor: 4.335

6. 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

7. Risk assessment in extrapolation of pharmacokinetics from preclinical data to humans.

Authors: Zvi Teitelbaum; Thierry Lave; Jan Freijer; Adam F Cohen
Journal: Clin Pharmacokinet Date: 2010-09 Impact factor: 6.447

8. Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.

Authors: Balaji M Agoram
Journal: Br J Clin Pharmacol Date: 2008-12-11 Impact factor: 4.335

9. 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

9 in total

6 in total

Review 1. Why maximum tolerated dose?

Authors: Hans G Stampfer; Genevieve M Gabb; Simon B Dimmitt
Journal: Br J Clin Pharmacol Date: 2019-07-22 Impact factor: 4.335

Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects.

1. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999.

Review 2. Developing drug prototypes: pharmacology replaces safety and tolerability?

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

Review 4. To scale or not to scale: the principles of dose extrapolation.

5. The return of the prodigal son and the extraordinary development route of antibody TGN1412 - lessons for drug development and clinical pharmacology.

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

7. Risk assessment in extrapolation of pharmacokinetics from preclinical data to humans.

8. Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.

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

Review 1. Why maximum tolerated dose?

Review 2. Translating the dose response into risk and benefit.

3. Goodbye to all that.

4. The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum.

Review 5. The Hitchhiker's Guide to Human Therapeutic Nanoparticle Development.

6. De-risking Clinical Trials: The BIAL Phase I Trial in Foresight.