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- Pharmacokinetic Clinical Trial Management Explained in Layma
- By: KATHY TIPPLEMAN
With drug and medical issues finding their way to the front pages of news papers more often as a new presidential election approaches, more and more people are trying to become more informed about them. What people are finding out far more often then not, is that the business of searching for effecive pharmacological therapy treatments for diseases is far more complex then they had originally considered it to be.One of Many Testing Procedures
The term “pharmacokinetic clinical trial management” is just one of the many phrases and terms that people will come across when looking into just how drugs are discovered and ultimately made available to the public for their benefit. What this long phrase referres to is the process by which a drug is tested under close medical supervision on people to see if it is ultimately safe to use.
The End of a Long Journey
By the time time a drug gets to the stage where it is getting put through pharmacokinetic clinical trials it has already been through years of previous development and testing procedures. This means that this testing phase, also commonly referred to as PK testing is one of the last steps before a drug is presented to the FDA for approval.
Most often,, pharmacokinetic clinical trial management will be subcontracted or outsourced to an outside firm for a number of reasons. One reason, is that because it is such an important step in the final stages of the extremely expensive process of developing a drug, drug companies will prefer that an unbiased entity perform the testing. Also, drug companies will subcontract PK testing management to protect themselves from being completely liable should the drug end up harming people.
Still one more reason for outsourcing PK testing is the the FDA often times like to see it done that way. Also, PK outsourcing will be done to double check PK testing that as previously been done in house by the drug company.
Written by Kathy Tippleman. Find the latest information on Pharmacokinetic Clinical Trial Management