The issues to be considered in global drug development

Affiliations

¹ Division of Biostatistics, Department of Pharmaceutical Sciences, Kitasato University Graduate School, 5-9-1 Shirokane, Minato-ku, Tokyo 108-8641, Japan. takeuchim@pharm.kitasato-u.ac.jp

Comment

Masahiro Takeuchi. Control Clin Trials. 2002 Feb.

. 2002 Feb;23(1):55-7.

doi: 10.1016/s0197-2456(01)00198-2.

¹ Division of Biostatistics, Department of Pharmaceutical Sciences, Kitasato University Graduate School, 5-9-1 Shirokane, Minato-ku, Tokyo 108-8641, Japan. takeuchim@pharm.kitasato-u.ac.jp

No abstract available

Comment on

The quality of conduct in Japanese clinical trials: deficiencies found in GCP inspections.
Ono S, Kodama Y, Nagao T, Toyoshima S. Ono S, et al. Control Clin Trials. 2002 Feb;23(1):29-41. doi: 10.1016/s0197-2456(01)00182-9. Control Clin Trials. 2002. PMID: 11852162
The quality and characteristics of clinical drug study notifications reviewed by the regulatory agency in Finland.
Keinonen T, Nieminen S, Saareks V, Miettinen P, Saano V, Ylitalo P. Keinonen T, et al. Control Clin Trials. 2002 Feb;23(1):42-51. doi: 10.1016/s0197-2456(01)00181-7. Control Clin Trials. 2002. PMID: 11852163