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Abstract

“Rules ” on how to prepare and present preclinical data in regulatory submissions are well established. Issues/delays in achieving a product license for a new drug can be avoided through a knowledge of these rules and good communication with regulatory agencies. In addition, preclinical evaluation of data needs to be written in a well-balanced, scientific manner to highlight the safety profile of the new drug in terms of human use and any deficiencies in the testing program. However, despite available help, preclinical documentation within submissions can be deficient in a number of ways. This paper highlights necessary regulatory requirements within the preclinical summaries of dossiers and comments on areas of neglect along with new challenges for the preclinical expert as well as exploring ways of avoiding adverse regulatory agency comments.

Keywords

Preclinical documents European United States and Japanese submission Pharmacodynamic data Pharmacokinetic data Toxicology data

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Preclinical Considerations for Regulatory Submissions

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