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Drug Discovery and Development
In this lecture ´´Drug Development and Regulation´´ is explained. Section one is about ´´Drug Discovery and Development ´´. Educator tells about the beginning of a new drug. In the next slide new drug development is discussed. After that drug discovery is explained.
Section two is about ‘’Drug Screening’’. At first educator introduces drug screening. Then selection of compound is discussed. After that identification of mechanism of action is pursued. In the next slide drug evaluation in animal models is focused. Additionally, information is conveyed on compound/lead optimization. In the last slide integrated drug discovery is reported.
Preclinical Safety and Toxicity Testing
Section three is about ‘’Preclinical Safety and Toxicity Testing’’. Educator tells that the dose makes the poison. Then information about safety tests is given. Moreover, goals of preclinical toxicity are discussed. At the end of this section limitations of preclinical testing is explained.
Confounding Factors in Clinical Trials and FDA
Section four is about ‘’Confounding Factors in Clinical Trials and FDA’’. Initially, the variable natural history of most diseases is covered. Next, the presence of other diseases and risk factors is discussed. After that subject and observer bias and other factors is explained. Educator tells that how to avoid subjects bias. Moreover, how to avoid observer bias is also highlighted.
Clinical Trials: The IND and NDA
Section five is about ‘’Clinical Trials: The IND and NDA’’. Primary emphasis is on investigational exemption for a new drug (IND). In the next slide phases of clinical trials are illustrated. Moving onward conflicts of interest are also focused. After that adverse drug reactions are described. Last part of this section includes the discussion of orphan drugs and treatment of rare diseases.