Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study.

Autor: Yuk, Inn H.¹ (AUTHOR), Koulis, Theo² (AUTHOR), Doshi, Nidhi¹ (AUTHOR), Gregoritza, Kathrin³ (AUTHOR), Hediger, Constanze³ (AUTHOR), Lebouc-Haefliger, Vanessa³ (AUTHOR), Giddings, Jamie¹ (AUTHOR), Khan, Tarik A.³ (AUTHOR) tarik.khan@roche.com

Publikováno v: AAPS Open. 11/14/2022, Vol. 8 Issue 1, p1-22. 22p.

INTERNATIONAL PERSPECTIVES : Poor Indoor Air Quality, Mold Exposure, and Upper Respiratory Tract Infections—Are We Placing Our Children at Risk?

Autor: Polyzois, Dimos, Polyzoi, Eleoussa, Wells, John A., Koulis, Theo

Publikováno v: Journal of Environmental Health, 2016 Mar 01. 78(7), 20-27.

Externí odkaz: https://www.jstor.org/stable/26330417

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A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry.

Autor: Gunter B; Retired, formerly Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA., Coleman D; Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA; coleman.daniel@gene.com., Goerke A; Global Manufacturing Science and Technology, F. Hoffmann-La Roche AG, Basel, Switzerland; and., Koulis T; Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA., Lamerz J; Nonclinical Biostatistics, F. Hoffmann-La Roche AG, Basel, Switzerland., Peng Y; Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2018 Mar-Apr; Vol. 72 (2), pp. 188-198. Date of Electronic Publication: 2017 Dec 14.