المؤلفون: Nieto A; Pharmaceutical Development & Supplies-PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland alejandra.nieto-pena@roche.com., Roehl H; Pharmaceutical Development & Supplies-PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Adler M; Pharmaceutical Development & Supplies-PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Mohl S; Pharmaceutical Development & Supplies-PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

المصدر: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2018 Nov-Dec; Vol. 72 (6), pp. 544-552. Date of Electronic Publication: 2018 May 31.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE

مواضيع طبية MeSH: Drug Packaging/*standards , Drug Storage/*methods , Technology, Pharmaceutical/*methods, Drug Packaging/instrumentation ; Elastomers/analysis ; Freezing ; Refrigeration ; Rubber/analysis ; Temperature ; Transportation/methods

المؤلفون: Nieto A; Pharmaceutical Development & Supplies-Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland alejandra.nieto-pena@roche.com., Roehl H; Pharmaceutical Development & Supplies-Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

المصدر: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2018 Jul-Aug; Vol. 72 (4), pp. 367-381. Date of Electronic Publication: 2018 Mar 15.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE

مواضيع طبية MeSH: Drug Packaging* , Drug Storage*, Rubber/*chemistry , Technology, Pharmaceutical/*methods, Cold Temperature ; Finite Element Analysis ; Freezing ; Materials Testing ; Temperature

المؤلفون: Brown H; Late-Stage Pharmaceutical and Processing Development, Roche., Mahler HC; Drug Product Services, Lonza., Mellman J; Biologics Technical Development and Manufacturing, Novartis., Nieto A; Late-Stage Pharmaceutical and Processing Development, Roche., Wagner D; Pharmaceutical Sciences Operations, Sanofi., Schaar M; Biological and Microbiological Services, Novartis., Mathaes R; Drug Product Services, Lonza., Kossinna J; Biologics Technical Development and Manufacturing, Novartis., Schmitting F; Development Sciences, Abbvie., Dreher S; Device Development, Roche; and., Roehl H; Late-Stage Pharmaceutical and Processing Development, Roche., Hemminger M; Device Development, Roche; and., Wuchner K; Drug Product and Device Methods, Janssen R&D kwuchne1@its.jnj.com.

المصدر: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2017 Mar-Apr; Vol. 71 (2), pp. 147-162. Date of Electronic Publication: 2016 Oct 27.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE

مواضيع طبية MeSH: Models, Theoretical* , Quality Control*, Drug Contamination/*prevention & control , Drug Packaging/*standards, Drug Packaging/instrumentation ; Drug Packaging/methods ; Drug Storage ; Materials Testing

المؤلفون: Nieto A; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; alejandra.nieto-pena@roche.com., Roehl H; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;, Brown H; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;, Adler M; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland;, Chalus P; Solid State Properties Analytics-Pharmaceutical Technical Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and., Mahler HC; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; Lonza AG, Drug Product Services, Basel, Switzerland.

المصدر: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2016 Jul-Aug; Vol. 70 (4), pp. 313-24. Date of Electronic Publication: 2016 Mar 28.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE

مواضيع طبية MeSH: Copper*/standards , Finite Element Analysis* , Glass*/standards , Nonlinear Dynamics* , Rubber*/standards, Drug Packaging/*methods, Drug Contamination/prevention & control ; Drug Packaging/instrumentation ; Drug Packaging/standards ; Humans ; Technology, Pharmaceutical/instrumentation ; Technology, Pharmaceutical/methods ; Technology, Pharmaceutical/standards

المؤلفون: Mathaes R; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland; roman.mathaes@lonza.com., Mahler HC; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Vorgrimler L; Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Steinberg H; Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Dreher S; Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Roggo Y; Complaints and Counterfeits, Quality Control for Commercial Bulk Products, F.Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland;, Nieto A; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Brown H; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Roehl H; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Adler M; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Luemkemann J; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Huwyler J; Department of Pharmaceutical Technologies, University Basel, Switzerland; and., Lam P; Pharmaceutical Processing and Technical Development, Genentech Inc., USA., Stauch O; Pharmaceutical Processing and Technical Development, Genentech Inc., USA., Mohl S; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;, Streubel A; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;

المصدر: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2016 May-Jun; Vol. 70 (3), pp. 218-29. Date of Electronic Publication: 2016 Jan 21.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE

مواضيع طبية MeSH: Torque*, Drug Packaging/*methods , Glass/*standards , Rubber/*standards , Technology, Pharmaceutical/*methods, Drug Packaging/instrumentation ; Parenteral Nutrition Solutions/standards ; Technology, Pharmaceutical/instrumentation

المؤلفون: Nieto A; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and alejandra.nieto-pena@roche.com., Roehl H; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and., Brown H; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and., Nikoloff J; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and., Adler M; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and., Mahler HC; Late-Stage Pharmaceutical and Process Development-Pharmaceutical Technical Development & Supplies Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and Lonza AG, Drug Product Services, Basel, Switzerland.

المصدر: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2016 Mar-Apr; Vol. 70 (2), pp. 120-33. Date of Electronic Publication: 2016 Jan 21.

نوع المنشور: Evaluation Study; Journal Article

بيانات الدورية: Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE

مواضيع طبية MeSH: Freezing*, Drug Packaging/*standards , Pharmaceutical Preparations/*standards , X-Ray Microtomography/*standards, Drug Contamination/prevention & control ; Drug Packaging/methods ; Drug Storage/methods ; Drug Storage/standards ; Glass ; X-Ray Microtomography/methods