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How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval
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The task of designing and making a suitable drug delivery system or dosage form that is fit for the market is enormous, and the process is usually not very efficient. It is a well-known fact that pharmaceutical manufacturing is one of the least efficient industries in the business world. It takes 10e15 years to develop a medicinal product, from discovery and patent application, through toxicity studies, pharmacology, clinical trials, scale-up, product registration and approval, and, finally, marketing and sales in conjunction with pharmacovigilance. Despite our best efforts, product quality oftentimes remains elusive and a lot of time and money are wasted in every unit operation compared, for example, to automotive or aircraft manufacturing. This book describes all stages of the process of making medical remedies from concept and discovery to the final consumer product. When we see this process in perspective, as a totally interconnected and interdependent effort of hundreds and thousands of highly qualified individuals, the intricacies and potential pitfalls of drug development become evident. It becomes patently apparent that there is a lot of room for improvement at every phase of the process. |
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2017-07-06 17:25:22, 7.4 M
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