In-use physicochemical and microbiological stability of biological parenteral products-Reference-Cited by-同舟云学术

In-use physicochemical and microbiological stability of biological parenteral products

Published:2015-03-01 Issue:5 Volume:72 Page:396-407
ISSN:1079-2082
Container-title:American Journal of Health-System Pharmacy
language:en
Short-container-title:

Author:

Ricci Margaret Speed¹,Frazier Michelle²,Moore Jamie³,Cromwell Mary⁴,Galush William J.⁴,Patel Ankit R.⁵,Adler Michael⁶,Altenburger Ulrike⁷,Grauschopf Ulla⁶,Goldbach Pierre⁶,Fast Jonas L.⁸,Krämer Irene⁹,Mahler Hanns-Christian¹⁰

Affiliation:

1. Drug Product Development, Genentech, South San Francisco, CA

2. Regulatory Affairs, Amgen, Thousand Oaks, CA

3. Early-Stage Pharmaceutical Development

4. Late-Stage Pharmaceutical Development

5. Early-Stage Pharmaceutical Development, Pharmaceutical Development, Pharma Technical Development Biologics U.S., Genentech, South San Francisco, CA

6. Late-Stage Pharmaceutical and Processing Development

7. Early-Stage Pharmaceutical Development and GLP Tox Supplies

8. Early-Stage Pharmaceutical Development and GLP Tox Supplies, Pharmaceutical Development and Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-LaRoche Ltd., Basel, Switzerland

9. Pharmacy Department, Medical Center of Johannes Gutenberg–University Hospital, Mainz, Germany, and Professor of Clinical Pharmacy, Pharmacy School of Johannes Gutenberg-University, Mainz

10. Pharmaceutical Development and Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-LaRoche Ltd

Publisher

Oxford University Press (OUP)

Subject

Health Policy,Pharmacology

Link

http://academic.oup.com/ajhp/article-pdf/72/5/396/28320910/ajhp0396.pdf

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4. Stability assessment of lyophilized intravenous immunoglobulin after reconstitution in glass containers and poly(vinyl chloride) bags;Parti;Biotechnol Appl Biochem,1997