The Japan PDMA will require pharmaceutical companies to include risk management plans in all applications, for new drug or biosimilar products

Author：

Publisher： Adis International

ISSN： 0114-9954

Source： Reactions Weekly, Vol.1, Iss.1431, 2012-01, pp. : 3-3

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Previous Menu Next

Abstract

Related content

Applications of a new device (spindle) for improved characterization of drug release (dissolution) of pharmaceutical products

By Qureshi S.A. Shabnam J.

European Journal of Pharmaceutical Sciences, Vol. 19, Iss. 4, 2003-07 ,pp. : 291-297

Elsevier

Access to resources Recommend Favorite

Pharmaceutical development of microbicide drug products

By Friend David R.

Pharmaceutical Development and Technology, Vol. 15, Iss. 6, 2010-12 ,pp. : 562-581

Informa Healthcare

Access to resources Recommend Favorite

Product Pipelines and Pharmaceutical Risk Management in the New Era of Strict Regulatory Scrutiny

By Sietsema William K.

International Journal of Pharmaceutical Medicine, Vol. 20, Iss. 2, 2006-01 ,pp. : 99-106

Adis International

Access to resources Recommend Favorite

Utilisation of Human Pharmacology Studies with Biomarkers for New Drug Applications in Japan

By Yasuo Kodama

Drugs in R&D, Vol. 6, Iss. 1, 2005-01 ,pp. : 21-34

Adis International

Access to resources Recommend Favorite

Statistical Assessment of Biosimilar Products

By Chow Shein-Chung

Journal of Biopharmaceutical Statistics, Vol. 20, Iss. 1, 2010-01 ,pp. : 10-30

Taylor & Francis Ltd

Access to resources Recommend Favorite