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During the onset of any clinical trial there are many factors and
variables to consider. Funding, time restraints, and regulatory
agency guidelines are factors that often influence which variables
will be studied, leaving other important information out of the
study. Preformulation in Solid Dosage Form Development covers every
topic of critical importance to the preformulation stages of drug
development. Serving as a handbook or stand-alone reference, this
text equips those in academia and the pharmaceutical industry with
both basic and applied principles for the characterization of
drugs, excipients, and products, and deals with the issues relating
to predictability, identification, and product development during
preformulation stages through Phase I of clinical trials. With
contributions from an international panel of experts in the field,
this guide: outlines an updated preformulation program for modern
drug development issues that includes particle morphology,
characterization, thermal analysis, and solubility methods contains
rational designs for the structure of formulation studies covers
the importance of preformulation design using artificial neural
networks and computational prediction techniques, and examines the
concepts of preliminary-preformulation discusses the typical
drug-excipient interactions that could occur during the course of
development and methods of characterization includes novel methods
to determine the physical and chemical stability of new
formulations reviews the structure, content, and format of the
preformulation report examines the significance of drug substance
physiochemical properties, in regulatory quality by design
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