The FDA Drug Development Process – an NF interpretation in Mold

Jacek Walkowicz

“Take better care of your health, please, please,” cautioned Blazing Night.
“I’m trying to,” said Rob.
“You’re not trying hard enough,” advised Blazing Night.

Blue Earth Water

The U.S. Food an Drug Administration (FDA) drug development process is presented here in a Naturalistic Fantasy (NF) Mold dialect:

discovery and development + preclinical 0.1% move to the next phase over several years + clinical PhaseOne 70% move to the next phase over several months, and then 33% in PhaseTwo over several months to two years, and then 25% to 30% in PhaseThree over 1 to 4 years + review 6 to 10 months + monitoring

or on average:

discovery and development + preclinical + clinical + review + monitoring: 1 drug out of 5,000 make to market over 12 years

20151221_112237


What about treatment, which can only be tested on humans?

discovery and development + clinical + review + monitoring?

Inducing emotions and measuring the…

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