The process of deriving the new drug starts in the laboratory. The chemical formula of the drug are composed in the lab and also called as the vitro testing. This type of testing performed before the drug can be tested on the animals or humans. The vitro testing gives the chemical description of the new drug and formulates the base and additional supplements. After vitro testing is done, the vivo testing starts on the animals. This process includes testing to figure out the possible side effects, level of toxicity, adverse effect and addiction. During this phase the pharmacodynamics of the drug is explored, which includes the calculation of the drug’s effect whether it desired or undesired and it always depends on the time and dose. During the testing on the animals also develops the frequency distribution curve, half-life, median effective dose (ED50), median toxicity dose and therapeutic index.
When the testing on animals are finished, pharmaceutical company sends the Investigational New Drug (IND) application to FDA. FDA has time to review the IND application, if any problems are found FDA can put a hold on the drug testing. After pharmaceutical companies receive the permission the testing can be started on humans. If new drug is permitted for testing on humans the company can start to search the volunteers. Testing on humans or clinical trials includes three phases: I, II and III.
Phase I usually lasts 1 ½ years. Drug Company or sponsor conduct the study on 10 to 100 volunteers who don’t have any medical conditions. Company must to provide the inform consent where has to be included all possible risks and known effects of the new drug. During phase I is studied the correct dose, side effects and the possible toxicity. During the test volunteers are provided with medical examinations. Also this part of the testing a pharmacokinetics are studied as well.
Phase II starts if the phase I didn’t show unacceptable increase of toxicity in the patients...
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