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The issue of how patents impact medicine has increased in significance within the last decade.The book provides an explanation of the current international infrastructure and explains how competing patent perspectives play a thus far unacknowledged role in promoting distortion and confusion.
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This comprehensive ebook covers all the aspects of ADME/PK modeling including solubility, absorption, formulation, metabolic stability, drug-drug interaction potential and a special delivery tool of drug candidates. The book provides an integrated view of fundamental ADME issues and challenges in early drug development from the aspect of practicing drug researchers. It also provides valuable help for the medicinal chemist in the process of multiple optimization.
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Generic drugs --- Drugs --- Pharmaceutical industry --- Prices.
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Counterfeit drugs --- analysis --- Counterfeit drugs --- analysis
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The examination of extractables and leachables from materials in contact with a drug product or the patient is growing in importance due to increased regulatory scrutiny from organisations such as the Food and Drugs Administration (FDA) and the European Medicines Agency (EMEA). Regulators are concerned with the interaction of various drug delivery devices, such as metered dose and dry powder inhalers (MDI and DPI) and now parenterals and ophthalmics are of increasing interest, as well as pharmaceutical process equipment. Extractables and leachables assessment of all materials and especially fr
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