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The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
The science required to transform a new discovery to a marketable new drug has definitely not kept pace with advances on the drug discovery side. [4] Pharmaceutical product development today is more of an art than science. Once the new drug discovery is made, product development and manufacturing are left to traditional "tried and true" practices.
AI is revolutionizing the drug delivery systems. AI technology can assist in identifying biological targets for pharmaceuticals, evaluating the pharmacological profiles of potential drugs, and analyzing genetic information; in the future, this could lead to drugs personalized to an individual, targeted cancer treatments, and edible vaccines.
With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.
Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. Pure drug substances are usually white crystalline or amorphous powders. Before the advent of medicine as a science, it was common for pharmacists to dispense drugs as is. Most drugs today are administered as parts of a dosage form.
Technology, which is transforming science, medicine, and research tools has increased the speed at which we can analyze data but we currently still must test the products which is a lengthy process. [3] Differences in the performance of medical care may be due to variation in the introduction and circulation of pharmaceutical innovations. [4]
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Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.