What we know is not what we implement in practice is the shadow in our development—walking a tight rope across the precipice with an elephant on my back. Is an Elephant on My Back the apt metaphor to replace the Six Blind Men and an Elephant and an Elephant in the Dark?

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HTTPS://DIANTPHARMA.COM/

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https://www.continuuspharma.com/about/the-team/

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HTTPS://WWW.FDA.GOV/NEWS-EVENTS/FDA-BRIEF/FDA-BRIEF-FDA-SUPPORTS-CRITICAL-RESEARCH-SPUR-INNOVATION-CONTINUOUS-MANUFACTURING-TECHNOLOGY-SUPPORT

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HTTPS://WWW2.SLIDESHARE.NET/A2ZPHARMSCI/A-PLATFORM-FOR-ASSURANCE-EFFICIENCY-AJAZ-AT-USP-PCM-MUMBAI-2017

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HTTPS://WWW.FDA.GOV/MEDIA/91721/DOWNLOAD

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QbD

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2010: “eenie, meenie, meinie,
mo,” the “Popperian Trap,” and
“Procrustean standards.”

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HTTPS://WWW.PHARMAMANUFACTURING.COM/BLOGS/
ONPHARMA/AJAZ-THE-AVENGER-ON-THE-NEED-FOR-
UNITY-FOR-PAT-AND-QBD-PHARMA-MUST-LEARN-
FROM-BIOPROCESSING/

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Woodcock, 9 April 2002

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Science necessary, but not sufficient.
Engineering necessary, but not sufficient.
Pharmaceutical Engineering Science.

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