Importance of Statistics



Importance of Statistics

1.

The use of statistics to support discovery and testing of new medicines has grown exponentially since the Kefauver-Harris Amendments, which became e?ective in 1962. The Kefauver-Harris Amendments required drug sponsors to prove a product's safety and e?cacy in controlled clinical trials in order to market the product(Chuang-Stein, 2004). Since the Amendments, the number of statisticians working in the pharmaceutical industry has greatly increased. This increase took another jump when the manufacturing process came under close scrutiny. As we move into the 21st century, the lure and the promise of genomics and proteomics will further intensify scientists' reliance on statistics. The need to enhance our overall knowledge about diseases, the need to insert more points into the decision-making process, and the need to bring economics into development strategy considerations will undoubtedly present new opportunities for statisticians. Even in the face of new opportunities, there are many well-established roles for statisticians in the pharmaceutical industry. The term “well-established” is a relative term since new roles will become more established over time. For example, trial simulation and modeling, viewed as new advancements a decade ago, have now become common practice to help design better trials across the pharmaceutical industry (Lendrem, 2002).

2.

In manufacturing applications, one of the regular problems we have to confront is that the measurements we take are imperfect. In cases where we can't improve the measurement process enough, we can come up with modified specification limits or guard bands to control the probabilities of classifying a bad part as good. Guard bands use the measurement system variation from a gauge R&R study to define a narrower range of numbers than the specification limits so that we avoid describing bad product as good.

Ideally, tracking quality metrics, such as the amount of active ingredient in product over ...