Literature DB >> 24137820

The evolution of nonclinical regulatory science: advanced therapy medicinal products as a paradigm.

Henrik Tang Vestergaard1, Lucia D'Apote, Christian K Schneider, Carla Herberts.   

Abstract

Mesh:

Year:  2013        PMID: 24137820     DOI: 10.1038/mt.2013.175

Source DB:  PubMed          Journal:  Mol Ther        ISSN: 1525-0016            Impact factor:   11.454


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  5 in total

1.  Preclinical efficacy in therapeutic area guidelines from the U.S. Food and Drug Administration and the European Medicines Agency: a cross-sectional study.

Authors:  Holger Langhof; William Wei Lim Chin; Susanne Wieschowski; Carole Federico; Jonathan Kimmelman; Daniel Strech
Journal:  Br J Pharmacol       Date:  2018-10-01       Impact factor: 8.739

2.  Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.

Authors:  James W McBlane; Parvinder Phul; Michaela Sharpe
Journal:  Pharm Res       Date:  2018-06-25       Impact factor: 4.200

3.  International regulatory considerations pertaining to the development of stem cell-based veterinary medicinal products.

Authors:  Byung Suk Jeon; Hee Yi; Hyun Ok Ku
Journal:  J Vet Sci       Date:  2021-01       Impact factor: 1.672

4.  Mesenchymal Stem Cells From Mouse Hair Follicles Reduce Hypertrophic Scarring in a Murine Wound Healing Model.

Authors:  Bernd Lethaus; Vuk Savkovic; Hanluo Li; Mirjana Ziemer; Ivana Stojanovic; Tamara Saksida; Danijela Maksimovic-Ivanic; Sanja Mijatovic; Goran Djmura; Dragica Gajic; Ivan Koprivica; Tamara Krajnovic; Dijana Draca; Jan-Christoph Simon
Journal:  Stem Cell Rev Rep       Date:  2022-01-26       Impact factor: 6.692

5.  Preclinical safety evaluation of chimeric antigen receptor-modified T cells against CD19 in NSG mice.

Authors:  Hairuo Wen; Zhe Qu; Yujing Yan; Chengfei Pu; Chao Wang; Hua Jiang; Tiantian Hou; Yan Huo
Journal:  Ann Transl Med       Date:  2019-12
  5 in total

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