Application of Statistics in Pharmaceutical Industry

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  • Topic: Obesity, Fatty liver, Non-alcoholic fatty liver disease
  • Pages : 15 (3861 words )
  • Download(s) : 214
  • Published : January 27, 2013
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Application of statistics in Pharmaceutical industry

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Although the advancement of medicine has prolonged and improved the life of many people over the years, it is important to remember that it is not an exact science. While some treatments do seem to offer a complete 'cure' for any particular ailment universally, the vast majority of medicinal treatments do not.

As such, it is important that statistics are used in medicine in order to justify the development and subsequent use of a particular drug or treatment; as well as identifying in the first place whether it is having the desired effect at all.

At the heart of the use of statistics in medicine is the seemingly insurmountable problem that everybody is different. Not only in a psychological sense, but a physiological sense too. While human beings may share similar organs, tissues and chemical compounds; how they are bonded, how we are composed and the effects different drugs have on the individual can be radically different from one person to the next.

Therefore, to measure the effectiveness of any form of medication, it is important to run trials where a wide variety of subjects are administered the drug. Firstly, this helps gage the effectiveness of the medicine when compared to, for example, a placebo. Subsequent statistical analysis can also give medical professionals and pharmaceutical companies the information they need to judge whether the medicine is an effective treatment for the majority of patients; and whether it is a cost-effective solution to a particular ailment.

Furthermore, once initial studies have been concluded and analyzed statistically, follow up studies can be initiated to investigate the initial statistical findings; providing further evidence as to the effectiveness of any form of treatment.

Why statistics is used in pharmacy?
1. Be able to make calculations such as dilutions accurately. 2. Be able to present data graphically and to interpret the shapes of graphs. 3. To be able to use functions involving logarithms and exponents. 4. To understand the process of differentiation and integration and to be able to perform these processes by a number of techniques. 5. To be able to quantify the relationship between variables using such techniques as regression and correlation. 6. Describe the statistical principles behind significance testing of experimental data. 7. Analyse statistically experimental data and determine statistical significance. 8. Appreciate the importance of statistics in pharmaceutical sciences.

One such example of use of statistics in pharmaceutical is its application in clinical trials wherein the efficacy of one drug is compared with the other.

Clinical trial: a nutritional supplement Viusid, in combination with diet and exercise, in patients with nonalcoholic fatty liver disease

SUMMARY
Background
Nonalcoholic fatty liver disease (NAFLD) is a significant health problem for which there is no universally accepted pharmacological treatment. The combination of weight loss and antioxidant drugs to ameliorate insulin resistance and improve steatosis, inflammation and fibrosis provides the rational for therapeutic trials.

Aim
To evaluate the efficacy and safety of a nutritional supplement Viusid in association with diet and exercise for NAFLD.
Methods
A randomized, controlled and parallel-group trial was conducted at a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). We randomly assigned 60 patients with liver biopsy-proven NAFLD to 6 months of treatment with a hypocaloric diet plus aerobic exercise daily and three Viusid sachets daily or a hypocaloric diet and exercise. Endpoints were improvement in the NAFLD activity score (NAS), fibrosis and normalization of serum aminotransferase levels.

Results
A significant improvement in steatosis, necroinflammation and fibrosis was seen in each group of treatment (P...
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