An FDA oncology analysis of immune activating products and first-in-human dose selection-Reference-Cited by-同舟云学术

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An FDA oncology analysis of immune activating products and first-in-human dose selection

Published:2016-11 Issue: Volume:81 Page:448-456
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Saber Haleh,Gudi Ramadevi,Manning Michael,Wearne Emily,Leighton John K.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference22 articles.

1. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies;Brennan;Monoclon. antibodies,2010

2. Cancer immunotherapy;Couzin-Frankel;Science,2013

3. Clinical development methodology for infusion-related reactions with monoclonal antibodies;Doessegger;Clin. Transl. Immunol.,2015

4. Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products;EMA,2007

5. Guideline on the evaluation of anticancer medicinal products in man;EMA,2013

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1. Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno‐Safety Technical Committee (ITC);Clinical Pharmacology & Therapeutics;2024-06-07

2. Translational PK/PD and the first-in-human dose selection of a PD1/IL15: an engineered recombinant targeted cytokine for cancer immunotherapy;Frontiers in Pharmacology;2024-06-03

3. Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology;Regulatory Toxicology and Pharmacology;2024-05

4. Preclinical and translational pharmacology of afucosylated anti‐CCR8 antibody for depletion of tumour‐infiltrating regulatory T cells;British Journal of Pharmacology;2024-03-14

5. Development of bispecific T cell engagers: harnessing quantitative systems pharmacology;Trends in Pharmacological Sciences;2023-12

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