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Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein Formulations.
Pegues, Melissa A; Szczepanek, Karol; Sheikh, Faruk; Thacker, Seth G; Aryal, Baikuntha; Ghorab, Mohamed K; Wolfgang, Steven; Donnelly, Raymond P; Verthelyi, Daniela; Rao, V Ashutosh.
Afiliación
  • Pegues MA; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Szczepanek K; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Sheikh F; Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Thacker SG; Laboratory of Immunology, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Aryal B; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Ghorab MK; Policy Development and Evaluation Branch 1, Division of Regulations, Guidance and Standards, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Wolfgang S; Cosmetics Regulatory Activities Branch, Cosmetics Division, Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, College Park, MD, 20740, USA.
  • Donnelly RP; Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Verthelyi D; Laboratory of Immunology, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA.
  • Rao VA; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA. ashutosh.rao@fda.hhs.gov.
Pharm Res ; 38(11): 1961-1975, 2021 Nov.
Article en En | MEDLINE | ID: mdl-34845573
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Polisorbatos / Excipientes / Ácidos Grasos / Rituximab Límite: Humans Idioma: En Revista: Pharm Res Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Polisorbatos / Excipientes / Ácidos Grasos / Rituximab Límite: Humans Idioma: En Revista: Pharm Res Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos