Concepedia

The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis

Kevin D. Seibert, Shanthi Sethuraman, Jerry D. Mitchell, Kristi L. Griffiths, Bernard McGarvey

Journal of Pharmaceutical Innovation · 2008 · 24 citations · 2 references

DOI

Concepts

References

2

API Quality by Design Example from the Torcetrapib Manufacturing Process

David J. am Ende, Karen S. Bronk, Jason Mustakis et al. · Journal of Pharmaceutical Innovation · 2007 · 52 citations

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Current thoughts on critical process parameters and API synthesis

William P. Ganzer, Joan A. Materna, Michael B. Mitchell · Pharmaceutical technology · 2005 · 20 citations

, , +15