Global regulatory considerations for unified assay specifications.

S. Patterson, L. Lin, J. Elchico, R. Fuchs, S. Powell, D. Redhair, M. Warwick, N. Solli, B. Méndez

Resultado de la investigación: Article

Resumen

When developing a biotechnology product for global registration, there are several aspects to evaluate in an effort to unify specifications. These include differences between the United States, Europe and Japan, and Rest-of-World (ROW) countries with regard to the respective regulatory guidelines and pharmacopoeias in force, the state-of-the-art of product testing analytical methods, and the interval between submitting a registration dossier to different countries. In terms of regulatory guidelines, one country may have a monograph or required specifications for particular tests, for example the potency that a product has to meet before clinical trials can be initiated. For pharmacopoeias, different assay methods are required for sterility, general safety, and pyrogen testing, so that one may have to test a specific lot of a product at two or three different times to evaluate the same parameter, because of specific testing differences required for each country's pharmacopoeia. In addition, the state of analytical methods is always evolving and better analytical techniques become available. Sometimes, from starting with one set of tests, and based on the time in development, new tests may be added to the existing list of release specifications, because new analytical techniques have become available. Examining the global registration approval process for Betaseron, (interferon beta-1b) illustrates when specifications were able to be unified and when they were not.

Idioma originalEnglish
Páginas (desde-hasta)45-48
Número de páginas4
PublicaciónDevelopments in Biological Standardization
Volumen91
EstadoPublished - 1997

Huella dactilar

Pharmacopoeias
Guidelines
Pyrogens
Biotechnology
Infertility
Japan
Clinical Trials
Safety
Interferon beta-1b

ASJC Scopus subject areas

  • Biotechnology
  • Immunology and Microbiology(all)
  • Public Health, Environmental and Occupational Health
  • Drug Discovery

Citar esto

Patterson, S., Lin, L., Elchico, J., Fuchs, R., Powell, S., Redhair, D., ... Méndez, B. (1997). Global regulatory considerations for unified assay specifications. Developments in Biological Standardization, 91, 45-48.
Patterson, S. ; Lin, L. ; Elchico, J. ; Fuchs, R. ; Powell, S. ; Redhair, D. ; Warwick, M. ; Solli, N. ; Méndez, B. / Global regulatory considerations for unified assay specifications. En: Developments in Biological Standardization. 1997 ; Vol. 91. pp. 45-48.
@article{154c85e9c9a34718b834c9e3e3e84bcf,
title = "Global regulatory considerations for unified assay specifications.",
abstract = "When developing a biotechnology product for global registration, there are several aspects to evaluate in an effort to unify specifications. These include differences between the United States, Europe and Japan, and Rest-of-World (ROW) countries with regard to the respective regulatory guidelines and pharmacopoeias in force, the state-of-the-art of product testing analytical methods, and the interval between submitting a registration dossier to different countries. In terms of regulatory guidelines, one country may have a monograph or required specifications for particular tests, for example the potency that a product has to meet before clinical trials can be initiated. For pharmacopoeias, different assay methods are required for sterility, general safety, and pyrogen testing, so that one may have to test a specific lot of a product at two or three different times to evaluate the same parameter, because of specific testing differences required for each country's pharmacopoeia. In addition, the state of analytical methods is always evolving and better analytical techniques become available. Sometimes, from starting with one set of tests, and based on the time in development, new tests may be added to the existing list of release specifications, because new analytical techniques have become available. Examining the global registration approval process for Betaseron, (interferon beta-1b) illustrates when specifications were able to be unified and when they were not.",
author = "S. Patterson and L. Lin and J. Elchico and R. Fuchs and S. Powell and D. Redhair and M. Warwick and N. Solli and B. M{\'e}ndez",
year = "1997",
language = "English",
volume = "91",
pages = "45--48",
journal = "Developments in Biological Standardization",
issn = "0301-5149",
publisher = "S. Karger AG",

}

Patterson, S, Lin, L, Elchico, J, Fuchs, R, Powell, S, Redhair, D, Warwick, M, Solli, N & Méndez, B 1997, 'Global regulatory considerations for unified assay specifications.', Developments in Biological Standardization, vol. 91, pp. 45-48.

Global regulatory considerations for unified assay specifications. / Patterson, S.; Lin, L.; Elchico, J.; Fuchs, R.; Powell, S.; Redhair, D.; Warwick, M.; Solli, N.; Méndez, B.

En: Developments in Biological Standardization, Vol. 91, 1997, p. 45-48.

Resultado de la investigación: Article

TY - JOUR

T1 - Global regulatory considerations for unified assay specifications.

AU - Patterson, S.

AU - Lin, L.

AU - Elchico, J.

AU - Fuchs, R.

AU - Powell, S.

AU - Redhair, D.

AU - Warwick, M.

AU - Solli, N.

AU - Méndez, B.

PY - 1997

Y1 - 1997

N2 - When developing a biotechnology product for global registration, there are several aspects to evaluate in an effort to unify specifications. These include differences between the United States, Europe and Japan, and Rest-of-World (ROW) countries with regard to the respective regulatory guidelines and pharmacopoeias in force, the state-of-the-art of product testing analytical methods, and the interval between submitting a registration dossier to different countries. In terms of regulatory guidelines, one country may have a monograph or required specifications for particular tests, for example the potency that a product has to meet before clinical trials can be initiated. For pharmacopoeias, different assay methods are required for sterility, general safety, and pyrogen testing, so that one may have to test a specific lot of a product at two or three different times to evaluate the same parameter, because of specific testing differences required for each country's pharmacopoeia. In addition, the state of analytical methods is always evolving and better analytical techniques become available. Sometimes, from starting with one set of tests, and based on the time in development, new tests may be added to the existing list of release specifications, because new analytical techniques have become available. Examining the global registration approval process for Betaseron, (interferon beta-1b) illustrates when specifications were able to be unified and when they were not.

AB - When developing a biotechnology product for global registration, there are several aspects to evaluate in an effort to unify specifications. These include differences between the United States, Europe and Japan, and Rest-of-World (ROW) countries with regard to the respective regulatory guidelines and pharmacopoeias in force, the state-of-the-art of product testing analytical methods, and the interval between submitting a registration dossier to different countries. In terms of regulatory guidelines, one country may have a monograph or required specifications for particular tests, for example the potency that a product has to meet before clinical trials can be initiated. For pharmacopoeias, different assay methods are required for sterility, general safety, and pyrogen testing, so that one may have to test a specific lot of a product at two or three different times to evaluate the same parameter, because of specific testing differences required for each country's pharmacopoeia. In addition, the state of analytical methods is always evolving and better analytical techniques become available. Sometimes, from starting with one set of tests, and based on the time in development, new tests may be added to the existing list of release specifications, because new analytical techniques have become available. Examining the global registration approval process for Betaseron, (interferon beta-1b) illustrates when specifications were able to be unified and when they were not.

UR - http://www.scopus.com/inward/record.url?scp=0031297230&partnerID=8YFLogxK

M3 - Article

C2 - 9413682

AN - SCOPUS:0031297230

VL - 91

SP - 45

EP - 48

JO - Developments in Biological Standardization

JF - Developments in Biological Standardization

SN - 0301-5149

ER -

Patterson S, Lin L, Elchico J, Fuchs R, Powell S, Redhair D y otros. Global regulatory considerations for unified assay specifications. Developments in Biological Standardization. 1997;91:45-48.