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New Pharmaceuticals, from idea to market
By Fredrik Pettersson
1. The idea In the first stage of drug development, you need an idea of what your indication will be (i.e. what decease or condition you want to treat). It doesn't necessarily have to be one specific indication, but a general area of what you are aiming for is usually required. Finding a way to treat the selected indication, there are several ways to achieve this. In later years, the method of high throughput screening (HTS) has been widely accepted in the pharmaceutical industries. In this screening-process, a vast amount of chemical substances are tested against specific binding sites (receptors, ion-channels etc) to find their so called affinity (the ability to bind to and affect for example the receptor). The idea behind this is that a certain indication is connected with a certain receptor and that a substance that has a high affinity against that receptor will be active in treating the decease/condition.
The major drawback in this kind of screening is that a decease is seldom caused by and thus treated by affecting only one receptor. Another way to screen for pharmacologically active substances is to test them in alive animals. This gives a lot more information about each substance, but is of course much more time consuming. 2. Optimizing a lead substance A lead substance is a chemical entity that is active in the pharmacological models. It probably does not have the optimized profile in all aspects, but it serves as a chemical starting point. From this substance the medicinal chemist optimize the “drugability” in several aspects such as physiochemical properties (solubility, stability etc), safety (minimize effect on unwanted areas of the body, possible carcinogenicity etc), pharmacokinetics (the way the drug is absorbed, distributed and excreted). There also is an issue of patentability of the structural class that has to be considered. A substance that is already known to have a certain effect is not patentable and therefore not interesting to develop since this will not be profitable. 3. Candidate Drug and clinical testing When the optimization procedure is done, the substance produced becomes a "candidate drug" and is tested for eventual toxicity in at least two animal species. This is essential to get approval from the FDA to proceed with testing in humans. If all tests indicates no toxicity the drug is eventually administered to humans in what is called a Phase I trial. In this trial the drug is given to healthy volunteers to examine the effect on the human body. Usually, prominent effects on the heart is specially monitored, as this is a side effect that is considered a great treat against further development. If the Phase I study is positive, Phase II follows with the aim of producing "proof of concept". This is done by administering the drug to patients suffering from the decease or condition that it is supposed to be effective in treating. To find out if the drug is effective in the patients, different methods (depending on the indication) to determine improvement is used. The number of patients in these studies is relatively small, and before a drug can be approved for marketing a larger study with a greater amount of patients, a Phase III study, is conducted. In this study the "proof of concept" is confirmed, and the possible side effects is determined and quantified. If the drug fulfills the criteria set up by the authorities the next step is launching it on the market.
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PLEASE VISIT THE CONTRIBUTOR'S WEBSITE
Bara Hander
Beauty parlour in the heart of Gothenburg
www.barahander.se
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This intel was contributed by Freddy
Freddy
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May, 2012
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