Quality by design in formulation and process development for a freeze-dried, small molecule parenteral product: a case study

Linas N. MockusPurdue University, West Lafayette, IN, USA

Timothy W. PaulPharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USA

Nathan A. PeasePharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USA

Nancy J. HarperPfizer Central Research, Groton, CT, USA

Prabir K. BasuPurdue University, West Lafayette, IN, USA

Elizabeth A. OslosPharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USA

Gregory A. SachaPharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USA

Wei Y. KuuPharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USA

Lisa M. HardwickPharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USA

Jacquelyn J. KartyPharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USA

Michael J. PikalSchool of Pharmacy, University of Connecticut, Storrs, CT, USA

Eun HeePurdue University, West Lafayette, IN, USA

Mansoor A. KhanFDA Center for Drug Evaluation and Research, Silver Spring, MD, USA

Steven L. NailPharmaceutical Development, Baxter Pharmaceutical Solutions, LLC, Bloomington, IN, USACorrespondence[email protected]

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