Non Clinical Studies : The Discovery Of A New Drug Without Involving Human Subjects

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Non clinical Studies for Biologic The discovery of a new drug without involving human subjects is called as non clinical studies. Goals of non-clinical testing of Biologics are: characterization of probable undesirable drug effects, identifying toxicities on organs, identifying convertibility of toxicity , characterization of pharmacokinetic report, characterization of favorable pharmacodynamic effects -proof of standard, guideline for safe application in human clinical studied, determination of a safe and practical starting dose, and offer monitoring strategy for the clinical study, offer adequate clinical data to conclude…show more content…
Discovery of New Biologics 1. Traditional Drug-Discovery Methods used trial and error approach where substances introduced to animals or in vitro on the target without any prior knowledge of what would be the result. The effects observed in these cases are examined the treatments for the disease. If a drug gives an effect to a pancreas cells, it can test for insulin related disease like diabetes. 2. Rational Drug Discovery approach starts with a hypothesis, typically the modification of a present known molecule giving a therapeutic effect. After selection of biologic, the next process is screening, this involves the screening of many variants of the prospective therapy. It is a common practice to use: High-Throughput Screening -Once a target has been chosen, it is generally cloned and expressed to produce thousands or millions of same copies which are then incubated separately known as screens and can be tested on the target (Rollins et al,. 2014). A positive reaction is called hits and further screened to determine if it acts on particular target or other targets too.”Hit” more targets produce a toxic effect in following trials in animals and humans. The best "hits" labeled as a lead compound, and can go for further testing and the others are labeled as backups. Other method uses -extracts from a natural product like plant-derived molecules, antimicrobials from microorganisms, active compounds. What to test in animal -in vivo testing - four commonly used species:
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