CTM [clinical trials materials] returns accountability: Compliance at the interface of GMP [good manufacturing practices] and GCP [good clinical practice]
Applied Clinical Trials 1999 July; 8(7): 52, 54-55
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Yonemori, K; Hirakawa, A; Ando, M; Hirata, T; Shimizu, C; Katsumata, N; Tamura, K; Fujiwara, Y (2011-06)This study aimed to examine the quality in oncology registration trials for new drug application (NDA) or supplemental new drug application (sNDA) as extensions of the indications for use in Japan based on Good Clinical ...
Commission Directive 2005/28/EC of 8 April 2005 Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of The Manufacturing or Importation of Such Products Unknown creator (Commission of the European Communities, 1995-04-09)
Draft Commission Directive Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of Manufacturing or Importation Of Such Products Unknown creator (European Commission, 2004-06-14)This proposed directive redrafts the original European Union clinical trials directive (2001/20/EC) that was developed to govern approval and monitoring of commercially-sponsored clinical research in countries of the ...