Abstract
Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in the MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian countries.
| Original language | English |
|---|---|
| Pages (from-to) | 493-500 |
| Number of pages | 8 |
| Journal | Journal of Toxicological Sciences |
| Volume | 34 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Oct 2009 |
| Externally published | Yes |
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Keywords
- Asian countries
- GLP
- MAD system
- Non-clinical safety study
- Pharmaceutical development
ASJC Scopus subject areas
- Toxicology
Cite this
Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development. / Sasaki, Madoka; Hinotsu, Shiro; Kawakami, Koji.
In: Journal of Toxicological Sciences, Vol. 34, No. 5, 10.2009, p. 493-500.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development
AU - Sasaki, Madoka
AU - Hinotsu, Shiro
AU - Kawakami, Koji
PY - 2009/10
Y1 - 2009/10
N2 - Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in the MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian countries.
AB - Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in the MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian countries.
KW - Asian countries
KW - GLP
KW - MAD system
KW - Non-clinical safety study
KW - Pharmaceutical development
UR - http://www.scopus.com/inward/record.url?scp=70349934724&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=70349934724&partnerID=8YFLogxK
U2 - 10.2131/jts.34.493
DO - 10.2131/jts.34.493
M3 - Article
C2 - 19797857
AN - SCOPUS:70349934724
VL - 34
SP - 493
EP - 500
JO - Journal of Toxicological Sciences
JF - Journal of Toxicological Sciences
SN - 0388-1350
IS - 5
ER -