Computer Applications In Pharmaceutical Research And Development Pdf

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computer applications in pharmaceutical research and development pdf

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About the book:. While there are a number of texts dedicated to individual aspects of pharmaceutical research and development, this unique contributed work takes a holistic and integrative approach to the use of computers in all phases of drug discovery, development, and marketing. It explains how applications are used at various stages, including bioinformatics, data mining, predicting human response to drugs, and high-throughput screening.

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Computers in Preclinical development

Chapter 4: Chemometric methods application in pharmaceutical products and processes analysis and control. Chapter 6: Computer-aided biopharmaceutical characterization: gastrointestinal absorption simulation. Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps , computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones.

A computer has high speed of calculation, diligence, accuracy, reliability, or versatility which has made it an integrated part in all business organizations. Online accounting facility, which includes checking current balance, making deposits and overdrafts, checking interest charges, shares, and trustee records. ATM machines which are completely automated are making it even easier for customers to deal with banks. Insurance companies are keeping all records up-to-date with the help of computers. Insurance companies, finance houses, and stock broking firms are widely using computers for their concerns.

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. New chemical entities NCEs, also known as new molecular entities or NMEs are compounds that emerge from the process of drug discovery. These have promising activity against a particular biological target that is important in disease. However, little is known about the safety, toxicity , pharmacokinetics , and metabolism of this NCE in humans.

Research and Development (R&D)

New product design and development is often a crucial factor in the survival of a company. In a global industrial landscape that is changing fast, firms must continually revise their design and range of products. This is necessary as well due to the fierce competition and the evolving preferences of consumers. A system driven by marketing is one that puts the customer needs first, and produces goods that are known to sell. In general, research and development activities are conducted by specialized units or centers belonging to a company, or can be out-sourced to a contract research organization, universities , or state agencies. Bank ratios are one of the best measures, because they are continuously maintained, public and reflect risk. In the United States, a typical ratio of research and development for an industrial company is about 3.


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Computer-Aided Applications in Pharmaceutical Technology

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Computers in preclinical development has become an integral part of pharmaceutical research and development. Pre-clinical development involves the testing of a prospective drug on animals to determine its safety and dose that can be used in humans. After this initial study on animals, an Investigation New Drug IND application needs to be filed with the regulatory authorities. An IND application may require as much as 50, pages of supporting documentation.

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