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Non-clinical Safety Evaluation of Biotherapeutics - Challenges, Opportunities and new Insights.
- Source :
-
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2016 Oct; Vol. 80S, pp. S1-S14. Date of Electronic Publication: 2016 Aug 27. - Publication Year :
- 2016
-
Abstract
- New challenges and opportunities in nonclinical safety testing of biotherapeutics were presented and discussed at the 5th European BioSafe Annual General Membership meeting in November 2015 in Ludwigshafen. This article summarizes the presentations and discussions from both the main and the breakout sessions. The following topics were covered in six main sessions: The following questions were discussed across 4 breakout sessions (i-iv) and a case-study based general discussion (v).<br /> (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Subjects :
- Animal Testing Alternatives methods
Animals
Animals, Genetically Modified
Antibodies chemistry
Antibodies immunology
Biological Products chemistry
Biological Products immunology
Biological Products pharmacokinetics
Cell- and Tissue-Based Therapy methods
Drug Compounding
Genetic Therapy methods
Humans
Models, Animal
Models, Theoretical
Patient Safety
Polyethylene Glycols adverse effects
Risk Assessment
Antibodies adverse effects
Biological Products adverse effects
Cell- and Tissue-Based Therapy adverse effects
Genetic Therapy adverse effects
Toxicity Tests methods
Subjects
Details
- Language :
- English
- ISSN :
- 1096-0295
- Volume :
- 80S
- Database :
- MEDLINE
- Journal :
- Regulatory toxicology and pharmacology : RTP
- Accession number :
- 27578450
- Full Text :
- https://doi.org/10.1016/j.yrtph.2016.08.012