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qiute621

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[资源] How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval

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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