A vision for patient-centric specifications for biologicals

Affiliations

• ¹ Independent Consultant, Bethesda, MD, 20817, USA. Electronic address: phil@drkrause.com.
• ² GSK, Via Fiorentina 1, 53100, Siena, Italy.
• ³ Novo Nordisk, Inc., 800 Scudders Mill Rd., Plainsboro, NJ, 08536, USA.
• ⁴ Independent Consultant, Seattle, WA, 98103, USA.
• ⁵ Amgen Inc, Thousand Oaks, CA, 91320, USA.
• ⁶ CMC Sciences, LLC, Germantown, MD, 20876, USA.
• ⁷ Centre for Vaccines, Clinical Trials, and Biostatistics, Biologic and Radiopharmaceutical Drugs Directorate, Health Canada, Ottawa, Ontario, K4A 1W2, Canada.