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Mendeley readers
| Chapter title |
ATMPs for Cancer Immunotherapy: A Regulatory Overview.
|
|---|---|
| Chapter number | 1 |
| Book title |
Tumor Immunology
|
| Published in |
Methods in molecular biology, January 2016
|
| DOI | 10.1007/978-1-4939-3338-9_1 |
| Pubmed ID | |
| Book ISBNs |
978-1-4939-3336-5, 978-1-4939-3338-9
|
| Authors |
Maria Cristina Galli, Galli, Maria Cristina |
| Editors |
Attilio Bondanza, Monica Casucci |
| Abstract |
This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described. |
Mendeley readers
The data shown below were compiled from readership statistics for 20 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 20 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 5 | 25% |
| Student > Bachelor | 4 | 20% |
| Student > Doctoral Student | 2 | 10% |
| Researcher | 2 | 10% |
| Student > Ph. D. Student | 2 | 10% |
| Other | 2 | 10% |
| Unknown | 3 | 15% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 5 | 25% |
| Biochemistry, Genetics and Molecular Biology | 3 | 15% |
| Medicine and Dentistry | 3 | 15% |
| Economics, Econometrics and Finance | 1 | 5% |
| Unspecified | 1 | 5% |
| Other | 2 | 10% |
| Unknown | 5 | 25% |