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Japanese points-to-consider documents

Items for Future Update of Japanese Points-to-Consider Document 107... [Pg.93]

Scientists from NIHS, PMDA, and JPMA collaborated to publish a Points-to-Consider document regarding the safety assessment of biopharmaceuticals in preclinical studies in 2002 [3], The collaboration team intended to clarify their interpretation of the ICH S6 guideline and share recent Japanese practices on this matter. However, it was written in Japanese. Thus the collaboration team made an English translation of the document and also collected comments on the contents from experts in the United States and the European. The experts agreed to most ideas presented in the Japanese Points-to-Consider document. They also suggested more clarification of some other ideas. In light of these comments, the collaboration team revised and published the English translation of the document, such that the nonnative Japanese could correctly understand the contents [4], In this section, I summarize the key points of the document, as they may be of some help to scientists in the pharmaceutical... [Pg.99]

Additional useful ideas included in the Japanese Points-to-Consider document are summarized that require further clarification. [Pg.103]

Points-to-Consider document helps industry scientists and regulatory reviewers understand the ICH S6 guideline. In particular, it is helpful for the clarification of case-by-case approaches to preclinical programs depending on the biopharmaceutical type. However, further updates of the Japanese Points-to-Consider document may be needed as newer types of biopharmaceuticals, technologies, and assays have developed. [Pg.109]


See other pages where Japanese points-to-consider documents is mentioned: [Pg.94]    [Pg.100]    [Pg.107]   


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