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Cleaning Process Development Using Design Of Experiments To Determine Critical Process Parameters
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Cleaning Process Development Using Design Of Experiments To Determine Critical Process Parameters
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12.20.20 Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products
By Ruijin Song and Andrew Walsh, Center for Pharmaceutical Cleaning Innovation (CPCI)
A simple time-to-clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.
By Mavra Nasir, Ph.D., Crystal Hsu, and Peter Bak, Ph.D., Back Bay Life Science Advisors
In Part 1 of this three-part series, we discussed nonalcoholic steatohepatitis (NASH), the market for treatments, the first wave of NASH drugs (at Phase 3) poised to change the management paradigm, and the currently ambiguous pricing/reimbursement landscape. Here in Part 2, we look at the most promising second wave of NASH drugs.