The Big Questions: Accelerating Proof Of Concept Using Solid State Chemistry

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Dates / Locations

October 12th - 9:00 AM to 5:00 PM, Clark, NJ (website) (map)

A lunch and breaks are included.

Course Fees

A fee of $500 is required to attend the course.  We will contact you by email about the exact course location and payment.

Course Description

This one-day course taught by Steve Byrn, George Zografi, and Xiaoming (Sean) Chen focuses on:

  • The "big questions" that must be answered in order to accelerate proof of concept
  • The importance of solid state chemistry in accelerating proof of concept
  • The idea that quality by design elements can be incorporated into a fast development program
  • Formulation development for proof of concept studies in an accelerated regime

The course will discuss use of polymorphs, amorphous forms, liquid crystals, nanoparticles, and cocrystals to improve solubility under an accelerated development regime. It covers the requirements for proof of concept studies especially from the CMC point of view. The course also discusses: (1) solubility and apparent solubility; (2) stability; (3) quality by design; (4) risk reduction and (5) intellectual property. Open discussion is welcome.

ie: Dr. Johnson, Mrs. Smith, Mr. Jackson

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Download Course Agenda (.doc)46.5 KB

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Powerful methods of analysis including IVIVC

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Informatics system to insure quality documents

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Strong IP assigned to client

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Quality by Design for formulations

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Rapid assessment of the risk of stability problems

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Fast screening for the right solid form....