Read the new article by Ken Miller
Available for free, unlimited access exclusively through ISYN Consulting.
Excerpts
“If one looks at the history of transdermal patch development as the discovery and identification of viable molecules, […] new molecules reach the transdermal market with the regularity approaching that of a clock that ticks once every two years.”
“The approach to transdermal product development before the QbD initiative was the same as that by which any complex product was developed from the time of the industrial revolution through the middle of the twentieth century. […] In my mind, it resembled the classic design houses of the auto industry (led by men like Enzo Ferrari, Harley Earl or, later, John DeLorian).”
“With increasing pressure to get equivalent products on the market; timelines were shortened, studies were limited and professional project management became part of transdermal product development leaving little room (or patience) for individual ‘style’. To survive and profit, companies had to have an efficient plan for transdermal product development in order to reach the market more than once.”
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