By Daria Mochly-Rosen, Kevin Grimes
Written via the founders of the SPARK application at Stanford college, this publication is a pragmatic advisor designed for professors, scholars and clinicians at educational examine associations who're attracted to studying extra in regards to the drug improvement method and the way to assist their discoveries develop into the unconventional medications of the long run. usually many almost certainly transformative easy technological know-how discoveries aren't pursued simply because they're deemed ‘too early’ to draw curiosity. There are basic, particularly low-cost issues that educational researchers can do to boost their findings to the purpose that they are often proven within the health facility or allure extra curiosity. each one bankruptcy widely discusses an incredible subject in drug improvement, from preclinical paintings in assay layout via scientific trial layout, regulatory matters and advertising tests. After the sensible assessment supplied the following, the reader is inspired to refer to extra distinctive texts on particular issues of interest.
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Additional resources for A Practical Guide to Drug Development in Academia: The SPARK Approach
Such shortcuts in development can be particularly valuable to resource-constrained academicians. When performing drug discovery research, we must be particularly attentive to the robustness of our experiments, because inability to reproduce academic data continues to be a sticking point when projects are transferred to industry. Our experiments must be appropriately blinded, statistically powered, and meticulously documented so that our findings are worthy of the large investment required for their further translation into a drug.
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” . When in doubt, check with your institution’s legal or compliance office or directly with the FDA. 1 Identifying Repurposing Opportunities When we have discovered a novel, validated drug target, screening a library of previously approved drugs for activity against our target may lead to a drug repurposing opportunity.
3. Does the compound interfere directly with the reporter readout used? 4. , cell-based versus in vitro)? 5. Is the activity reversible after washout? ) 6. Is there evidence of a structure–activity relationship (SAR) for the active compounds? Are there related inactive compounds in the library? 7. Is the compound just generally reactive under the assay conditions? , 5 mM lysine dissolved in assay buffer). Following these steps should result in a well-characterized primary screening assay and a set of secondary assays suitable for a HTS campaign in academia or one of the NIH Molecular Libraries Probe Production Centers Network.