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This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R wil...
This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in Ch...
The aim of this major reference work is to provide a first point of entry to the literature for the researchers in any field relating to structural integrity in the form of a definitive research/reference tool which links the various sub-disciplines that comprise the whole of structural integrity. Special emphasis will be given to the interaction between mechanics and materials and structural integrity applications. Because of the interdisciplinary and applied nature of the work, it will be of interest to mechanical engineers and materials scientists from both academic and industrial backgrounds including bioengineering, interface engineering and nanotechnology. The scope of this work encomp...
Includes list of members.
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Despite being regarded as the most common toxicological target in the endocrine system, the adrenal gland has often been neglected in regulatory testing. Adrenal Toxicology addresses the increased interest in adrenocortical toxicology and the need for a resource that makes techniques available to examine adrenal endocrine disruption. Examining curr