The Discovery Of New Drug Without Involving Human Subjects

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Non clinical Studies The discovery of new drug without involving human subjects is called as non clinical studies. Goals of non-clinical testing of Biologics are: characterization of potential adverse drug effects, identify end organ toxicities, identify reversibility of toxicity , characterization of pharmacokinetic profile, characterization of beneficial pharmacodynamic effects -proof of principle , guideline for safe use in human clinical studied determination of a safe and reasonable starting dose and provide monitoring guidelines for the clinical study, provide sufficient clinical data to conclude that there no…show more content…
Traditional Drug-Discovery Methods used trial and error approach substances were introduce 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. For example, if a drug gives an effect to a pancreas cells, it can tested 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 selected, it is usually cloned and expressed to generate thousands or millions of exact copies which are then incubated separately known as screens and can be test on the target (Rollins et al,. 2014) A positive reaction are called hits and further screened to determine if it act 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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