The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies

Author:

Muller Patrick Y,Milton Mark,Lloyd Peter,Sims Jennifer,Brennan Frank R

Publisher

Elsevier BV

Subject

Biomedical Engineering,Bioengineering,Biotechnology

Reference22 articles.

1. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412;Suntharalingam;N Engl J Med,2006

2. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers;CDER/FDA,2005

3. Guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products;EMEA/CHMP,2007

4. The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development;Milton;Toxicol Pathol,2009

5. First-in-Man (FIM) clinical trials post-TeGenero: a review of the impact of the TeGenero trial on the design, conduct, and ethics of FIM trials;Nada;Am J Ther,2007

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