New Pharmaceuticals Essay Example | Topics and Well Written Essays - 750 words

spic-and-span Pharmaceuticals - Essay causeSecondly, the labeling of the medicine is verified and its contents be determined. Thirdly, the methods of manufacturing adopted are verified for their effectiveness in retaining the medicates identity, strength, quality and purity in adequate measures. The NDA has been so designed as to reveal the solid history behind development the drug such as animal studies, human clinical trials, instrument of action of the drug on the body, methods of manufacture and packaging (NewDrugApplication). Development Process Discovery or blueprint of a new drug usually involves selecting a few say five out of to a greater extent than 5,000 new compounds that are considered safe enough to conduct trials in humans and pre-clinical evaluations lasting for three to hexad years. From the five compounds selected, only one is approved by the FDA for introduction in the market for treatment. The research deal involves the following sequence Target identifi cation, target prioritization/validation, lead identification and lead optimization. Once the drug is optimized by dint of in vivo and in vitro studies involving animals, it is used in human volunteers as an investigational drug. There are a account of phases of testing of drug on humans consisting of cast I Clinical studies, Phase II clinical studies, Phase III clinical studies, Phase IIIb/IV studies and Post Approval studies. Phase I meant for bridle 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(prenominal) hundr ed to thousands of volunteering patients for whose diseases the drug is intended. Phase III b is usually the immediate pre-approval head. Post approval stage involves testing of the drug introduced in the market focusing on unknown side effects and different risk factors (PPD). Cost of development It has been estimated that new drug discoveries have increased human life foreboding and economic gains from new drugs are estimated to be more than $ 500 billion per year. In view of the to a higher place said prolonged development phases, a company has to incur costs not less than $ 800 one thousand million to $ 2 billion per drug. In once instance, Pfizer has reported an investment of $ 800 million for Phase III trials alone(predicate) 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 to begin with studied. It takes at least 12 to 15 years for discovery and development of a drug. Though the glaring 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