A summary provides a synopsis of those issues and concludes that the complex technical nature of pharmaceutical development and manufacturing offers many opportunities for the effective use of statistical and optimization thinking and methods. The pharmaceutical industries undergoing rapid change and facing numerous challenges including the demand of global competition, the need to speed up the drug development process. The FDA’s expectation for submission of new drug or new dosage forms. Statistical input in sampling and testing for quality control, stability testing ,process validation design of preclinical protocol including statistical methods and appropriate statistical analysis of resulting data , are application routinely applied by pharmaceutical industries to satisfy both internal requirement and FDA’s recommendation . Statistical thinking and methods plays significant role in addressing these issues. This article provides an overview of the use of statistical thinking and techniques in manufacturing function of the pharmaceutical industries. The exposition includes the various techniques by which one may effectively treat the scientific data normally obtained in actual analytical procedure.
Loading....