By Daria Mochly-Rosen, Kevin Grimes
Written by way of the founders of the SPARK software at Stanford college, this e-book is a pragmatic advisor designed for professors, scholars and clinicians at educational learn associations who're attracted to studying extra in regards to the drug improvement method and the way to aid their discoveries develop into the radical medications of the longer term. frequently many very likely transformative simple technological know-how discoveries will not be pursued simply because they're deemed ‘too early’ to draw curiosity. There are easy, rather not pricey issues that educational researchers can do to boost their findings to the purpose that they are often established within the sanatorium or allure extra curiosity. every one bankruptcy largely discusses a major subject in drug improvement, from preclinical paintings in assay layout via medical trial layout, regulatory concerns and advertising checks. After the sensible evaluate supplied right here, the reader is inspired to refer to extra certain texts on particular themes of interest.
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Extra info for A Practical Guide to Drug Development in Academia: The SPARK Approach
Like you, I take a great pride in our work in academia. I felt that conducting blinded studies, using several species, and reproducing the work in independent labs all combined to ensure high quality and valid data. That was not enough, I quickly learned. 2: Key Terms and Abbreviations CSO: Chief Scientific Officer Preclinical animal studies: animal studies done to validate a disease target and test the performance of a molecule prior to moving into human testing p-value: a statistical measure of the probability of obtaining a result at least as extreme as the one observed.
These discussions should help define variables such as endpoints, duration of treatment, number of doses, size of study, etc. As these are likely to change as the program evolves, test the boundaries of the proposed numbers. For example, if the clinician recommends that we treat this patient population for 1 month to see a significant change in a particular endpoint, we should query how likely it is that we would end up treating for 2 months or if it would be feasible to treat for 2 weeks instead.
Advancing a repurposed compound to clinical study may also require the filing of an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) or relevant national regulatory agency (if the clinical studies will be conducted outside of the USA). , a new drug label, or if the research involves a “route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product” .
A Practical Guide to Drug Development in Academia: The SPARK Approach by Daria Mochly-Rosen, Kevin Grimes