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Indeed, as the charts in this report shows: http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM247465.pdf, the number of FDA approved drugs (and the number of applications as well) is slowly decreasing. In a recent (May 2011) letter to Nature, author John Arrowsmith writes: “the Phase II success ...Read more
Genetic mutations are a result of metabolic issues not the other way round. Even clinical trials which are supposed to have worked well, in my experience, may not be as portrayed. For example my wife was on a particular phase ...Read more
CROs select sites for clinical trials in which way
When it comes to choosing sites for a clinical trial, it’s all about relationships. The relationship between sponsors, clinical research organizations, and study sites is the key to improving clinical trial performance.
When it comes to choosing sites for a clinical trial, it’s all about relationships. The relationship between sponsors, clinical research organizations, and study sites is the key to improving clinical trial performance.
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Ananya Pawar
Important to know how drugs are developed The process is long and tedious prior to approval of any new drug by regulatory agencies . Idea is to ensure that drug should show it's effectiveness in a convincing manner and it's effects should weigh over it's side effects before it reaches market . ProceRead more
Important to know how drugs are developed
The process is long and tedious prior to approval of any new drug by regulatory agencies . Idea is to ensure that drug should show it’s effectiveness in a convincing manner and it’s effects should weigh over it’s side effects before it reaches market .
Process of drug development involves various stages :
• in Vitro/Cell-based studies
• in Vivo/Animal Model studies
• Phase 1 trials –
• Phase 2 trials
• Phase 3 trials
• Approval
• Phase 4 trials
Ninety percent of new chemical entities (NCEs) entering clinical trials fail, more than 80 % fail at phase 1 and 2 level
Phase 1
• Initial introduction of an investigational new drug into humans
• Usually conducted in healthy volunteer subjects
Phase 2
• Phase 2 includes early controlled clinical studies conducted to obtain some preliminary data on the efficacy of the drug
Phase 3
• Phase 3 studies are expanded, controlled, and uncontrolled trials.
• These studies usually include several hundred to several thousand people
Phase 4
Phase 4 trials are done after a drug has received a market approval. These trials are monitoring drugs that are available for doctors to prescribe, rather than experimental drugs that are still being developed.
Pharmaceutical companies run Phase 4 trials to find out:
• More about safety and side effects of the drug
• What the long-term risks and benefits
Clinical research and trials are conducted at multiple sites all across the world in different patient population
This all involves huge resources and big budget . But in the end if we have a drug which is helpful to mankind then it’s worth the money and sweat !!
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