Investigative New Drug Testing Testing And Development...

Testing and development of new drugs can be a long, strenuous and costly project for a manufacturing company. In 2003 drug companies spent $2.4 million on bringing new drugs to the market. By 2005 that figured ballooned to $802 million. If you think that is crazy, now experimental drugs cost pharmaceutical companies $312 million just for the post approval process of the drug and a whopping $2.9 billion to place the new drug on the market. The whole process can take 8-12 years until completion. First a drug must be approved to be transferred across state lines. If a sponsor (usually a manufacturer or potential marketer) want to ship the product to a clinical trial facility(s) an IND (Investigative New Drug Application) must be filed.†¦show more content†¦They also must provide information regarding clinical protocols and investigator information. This information is used to ensure that the physicians overseeing the administration of the drugs are qualified to fulfill their clinical obligations. Once the IND is submitted the sponsor must wait 30 calendar days before initiating any clinical trials. During the preclinical phases the drug was subjected to in vivo testing. In vivo testing is when a drug is tested in animals and is monitored for chromosomal damage and how toxicity levels are effected. During to clinical phases the drug goes through 3 phases of testing. Phase 1 is when a small group 20-100 of healthy volunteers are administered the drug dosage in small doses and gradually increased. This phase’s purpose to establish dosage and compound safety. Phase 2 is quite the same as phase 1 but with a larger group 100-300 people that are drug candidates. This phase determines effective dosage, methods of delivery and dosing intervals. Phase 3 and final phase is same as its predecessor phase but with a much larger group of 1000-3000 individuals that are drug candidates. This phase provides patients with the drug in the exact form as it will be given will on the market and is compared to similar drugs on the market. Oftentimes double-blind studies are done in this phase with the drug and a placebo. After theShow MoreRelated Drug Policy Essay1017 Words   |  5 Pages The President’s Drug Policy Introduction nbsp;nbsp;nbsp;nbsp;nbsp;The following is a summary of the President’s policy emphasizing on the President’s stated objectives. Stopping drug use before it starts, providing drug treatment, and attacking the economic basis of the drug trade are the main positions the President stressed. The President’s policy was analyzed by the important tasks played by law enforcement, schools and the community. 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