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- W1498355909 abstract "For pharmaceutical products under development, there are some basic rules that must be followed during transformation of an idea into a product in order to ensure patient protection. As the patient may not know how to precisely define his or her wants or needs and because society as a whole requires that the patient be protected, all pharmaceutical products intended for human use are controlled. The basis for design of a pharmaceutical product is the quality target product profile (QTPP) defined in ICH Q8R1. Where a large number of factors, which could potentially impact the success of the process, are identified, design of experiment (DOE) allows a systematic method to reduce the number of tests needed to study these factors as well as to study potential interactions between parameters. The use of risk management tools in process development and manufacture of clinical trial material allows for increased process understanding." @default.
- W1498355909 created "2016-06-24" @default.
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- W1498355909 date "2013-03-03" @default.
- W1498355909 modified "2023-09-27" @default.
- W1498355909 title "Process Development and Clinical Product Manufacturing" @default.
- W1498355909 doi "https://doi.org/10.1002/9781118514399.ch6" @default.
- W1498355909 hasPublicationYear "2013" @default.
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