Overview of a quality assurance/quality control compliance program consistent with FDA regulations and policies for somatic cell and gene therapies: a four year experience

Autor:	Jean Ko Stewart, Yuan-Jin Shen, Gary C. du Moulin, Carla Charles, Dylan Hamilton, Zorina Pitkin, Evelyn Conti
Rok vydání:	1994
Předmět:	medicine.medical_specialty Somatic cell business.industry media_common.quotation_subject Genetic enhancement Clinical trial Clinical research Immunology Health care medicine Mandate Quality (business) Intensive care medicine business Quality assurance media_common
Zdroj:	Cell Culture Engineering IV ISBN: 9789401041140
DOI:	10.1007/978-94-011-0257-5_39
Popis:	Somatic cell and gene therapy involve the application of biological technologies to an individual patient through the use of living cells which provide a therapeutic benefit (Aliski, 1991). Various forms of cellular and gene therapies are being developed and evaluated in an increasing number of clinical trials for congenital and acquired disorders. The potential and progress of these therapeutic applications have resulted in an increasing effort by the Food and Drug Administration (FDA) to develop the regulatory framework under which these therapeutic approaches would insure safety and efficacy, the primary mandate of the FDA.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::7ecb4a7e00fbbe4c99eba8aa9b178a48 https://doi.org/10.1007/978-94-011-0257-5_39 Zobrazit plný text záznamu