IN the introduction it is stated that this book represents the reproduction of a series of lectures delivered in the College de France on the principles involved in the methods of analytical chemistry ...
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts. Analytical quality ...
This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts. By using a lifecycle ...
In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
The data generated using analytical methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the reliability of this data it is crucial that the ...
Thought and foresight into method development stages can ensure costly errors and delays are avoided later on. Method development is a critical and continuous process that, if optimized, ensures ...
Advancing analytical techniques is all well and good, but unless those advances in technology are accompanied by matching strides in technique management, the true potential of better methods may not ...
The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...
The control of unwanted chemicals in food, such as residues of pesticides or veterinary drugs used in food production, or natural contaminants such as mycotoxins, remains an area of high importance to ...
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