National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials
| Autor: | Mirunalini Ravichandran, Priyadharsini Rajendran, Kiruthika Sivagourounadin |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Medicine (General) business.industry Genetic enhancement Drug administration Review Article General Medicine Guideline Medical research gene therapy Clinical trial gene therapy products indian council of medical research R5-920 Family medicine media_common.cataloged_instance Medicine Road map Product (category theory) guidelines European union business media_common |
| Zdroj: | Perspectives in Clinical Research, Vol 12, Iss 3, Pp 118-125 (2021) Perspectives in Clinical Research |
| ISSN: | 2229-3485 |
| Popis: | The “National Guidelines for Gene Therapy Product (GTP) Development and Clinical Trials” prepared by the Indian Council of Medical Research and Department of Biotechnology in 2019 came as a welcome step in the process of regulation of gene therapy research, as there was a lack of Indian guidelines earlier specific to gene therapy. Indian researchers have taken their step in setting the path of gene therapy research, and this guideline serves to provide the standards starting from its development up to translation to new drug including the ethical, scientific, and regulatory requirements to be followed during the conduct of trial. The Indian guidelines were framed with reference to United States-Food and Drug Administration and European Union guidelines on gene therapy. It is the responsibility of all the stakeholders involved in the development of GTP to adhere to the national guidelines. This review provides an outline of the Indian regulatory guidelines on GTP. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
| Nepřihlášeným uživatelům se plný text nezobrazuje | K zobrazení výsledku je třeba se přihlásit. |