A roadmap towards a human-centric safety assessment of advanced therapy medicinal products

Author:

Chien Hsiao-TzuORCID,de Leeuw Victoria C.,van Esterik Joantine C.J.,Russel Frans G.M.,Kienhuis Anne S.,Theunissen Peter T.,van Meer Peter

Publisher

Elsevier BV

Reference26 articles.

1. Using artificial intelligence methods for systematic review in health sciences: a systematic review;Blaizot;Res. Synth. Methods,2022

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3. Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach;Chien;Regul. Toxicol. Pharmacol.,2023

4. Guideline on the Principles of Regulatory Acceptance of 3Rs (Replacement, Reduction, Refinement) Testing Approaches,2016

5. Draft Guideline on Quality, Non-clinical and Clinical Requirements for Investigational Advanced Therapy Medicinal Products in Clinical Trials,2019

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