New Pharmaceuticals - Essay Example

Secondly, the labeling of the drug is verified and its contents are determined. Thirdly, the methods of manufacturing adopted are verified for their effectiveness in retaining the drug’s “identity, strength, quality and purity” in adequate measures. The NDA has been so designed as to reveal the whole history behind development the drug such as animal studies, human clinical trials, mechanism of action of the drug on the body, methods of manufacture and packaging (NewDrugApplication). Development Process Discovery or invention of a new drug usually involves selecting a few say five out of more than 5,000 new compounds that are considered safe enough to conduct trials in humans and pre-clinical evaluations lasting for three to six years.

From the five compounds selected, only one is approved by the FDA for introduction in the market for treatment. The research process involves the following sequence; Target identification, target prioritization/validation, lead identification and lead optimization. Once the drug is optimized through in vivo and in vitro studies involving animals, it is used in human volunteers as an investigational drug. There are a number of phases of testing of drug on humans consisting of Phase I Clinical studies, Phase II clinical studies, Phase III clinical studies, Phase IIIb/IV studies and Post Approval studies.

Phase I meant for verification of safety and tolerability in humans lasts for six to nine months. Usually 20 to 100 healthy volunteers are given the investigational drug for a short term for documentation as to how the drugs is absorbed, distributed, metabolized in the body and excreted from the body. Phase II determines the effectiveness and further safety of the candidate drug on the humans. This phase would last for a period of six months to three years. In Phase III, the drug undergoes randomized and blind clinical trials involving several hundred to thousands of volunteering patients for whose diseases the drug is intended.

Phase III b is usually the immediate pre-approval stage. Post approval stage involves testing of the drug introduced in the market focusing on unknown side effects and other risk factors (PPD). Cost of development It has been estimated that new drug discoveries have increased human life expectancy and economic gains from new drugs are estimated to be more than $ 500 billion per year. In view of the above said prolonged development phases, a company has to incur costs not less than $ 800 million to $ 2 billion per drug.

In once instance, Pfizer has reported an investment of $ 800 million for Phase III trials alone for one drug. The cost is huge because the U.S. F.D.A. approves just one drug out of five compounds selected out of 5,000 to 10,000 compounds originally studied. It takes at least 12 to 15 years for discovery and development of a drug. Though the patent period is 20 years for a drug, effective period available to the drug developer is hardly 12 years in view of the time consumed in the developmental period when the drug developer is allowed to use the drug along the way on volunteers (Masia n d ) Works Cited Masia, Neal.

The Cost of Developing a New Drug, Focus on Intellectual Prperty Rights. n.d . 27 March 2011