(Q26825211)

Susanne Ausborn

2

1 reference

Claire Beggs

3

1 reference

Martin Bopst

4

1 reference

Angelika Joos

5

1 reference

Alexandra A. Kitashova

6

1 reference

Olga Kovbasenco

7

1 reference

Claus-Dieter Schiller

8

1 reference

Martina Schwinger

9

1 reference

Natalia Semenova

10

1 reference

Lilia Smirnova

11

1 reference

Fraser Stodart

12

1 reference

Thomas Visalli

13

1 reference

Lisette Vromans

14

1 reference

language of work or name

1 reference

November 2014

1 reference

Journal of Pharmaceutical Sciences

1 November 2014

4 references

20 June 2019

19 September 2019

2 October 2020

16 July 2021

5 references

20 June 2019

19 September 2019

2 October 2020

16 July 2021

103

1 reference

page(s)

3349-55

1 reference

issue

11

1 reference

Creative Commons Attribution-NonCommercial 3.0 Unported

copyright license

4 references

20 June 2019

19 September 2019

2 October 2020

Forced degradation of therapeutic proteins.

16 July 2021

cites work

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

Protein-excipient interactions: mechanisms and biophysical characterization applied to protein formulation development

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

An improved abnormal toxicity test by using reference vaccine-specific body weight curves and histopathological data for monitoring vaccine quality and safety in Japan

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

The international symposium on regulatory testing and animal welfare: recommendations on best scientific practices for biological: safety and potency evaluations

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

Reduction of animal use in human vaccine quality control: opportunities and problems

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

A good practice guide to the administration of substances and removal of blood, including routes and volumes

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

A 4R concept for the safety testing of immunobiologicals.

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

Alternatives to animals in the development and control of biological products for human and veterinary use. The role of the European Pharmacopoeia

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

WHO activities towards the three Rs in the development and control of biological products

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

Animal experiments in the context of quality control of pharmaceuticals. Review of the European Pharmacopoeia, 4th edition, 2002

28 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

Is the abnormal toxicity test still relevant for the safety of vaccines, sera and immunoglobulins?

28 November 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4278562

Is the test for abnormal toxicity, general safety or innocuity necessary for vaccines?

28 November 2018

1 reference

12 December 2020

Elimination of abnormal toxicity test for sera and certain vaccines in the European Pharmacopoeia

1 reference

12 December 2020

[Abnormal toxicity - a relevant safety test under GLP- and GMP-conditions in the production of vaccines?]

1 reference

12 December 2020

WHO Expert Committee on Biological Standardization

1 reference

12 December 2020

WHO Expert Committee on Biological Standardization

1 reference

12 December 2020