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ICH issued the S1B(R1) "Appendix to the Guidelines for Drug Carcinogenicity Tests" on May 10, proposing the "weight of evidence" method to guide whether the two-year rat study will increase the value of evaluating the carcinogenic risk of drugs.
ICH issued the S1B(R1) "Appendix to the Guidelines for Drug Carcinogenicity Tests" on May 10, proposing the "weight of evidence" method to guide whether the two-year rat study will increase the value of evaluating the carcinogenic risk of drugs.
The proposed guidelines provide more detailed guidance for drug developers who are considering the need for rodent studies to assess carcinogenicity.
In June 2012, the ICH steering committee approved a concept document that supports the reduction or elimination of the need for rodent carcinogenicity testing, with the goal of developing drugs faster and cheaper, reducing ethical issues and reducing animal use.
In June 2012, the ICH steering committee approved a concept document that supports the reduction or elimination of the need for rodent carcinogenicity testing, with the goal of developing drugs faster and cheaper, reducing ethical issues and reducing animal use.
The proposed guidelines provide more detailed guidance for drug developers who are considering the need for rodent studies to assess carcinogenicity.
In June 2012, the ICH steering committee approved a concept document that supports the reduction or elimination of the need for rodent carcinogenicity testing, with the goal of developing drugs faster and cheaper, reducing ethical issues and reducing animal use.
In June 2012, the ICH steering committee approved a concept document that supports the reduction or elimination of the need for rodent carcinogenicity testing, with the goal of developing drugs faster and cheaper, reducing ethical issues and reducing animal use.
ICH S1B(R1) is currently in the second stage of guideline formulation.
All ICH parties have reached a scientific and technical consensus on this technical document, and issued and collected feedback.
Once this appendix is promulgated and implemented, it will be used together with ICH S1A "Guidelines for the Necessity of Drug Carcinogenic Toxicity Studies", S1B "Drug Carcinogenicity Tests" and S1C(R2) "Dose Selection for Drug Carcinogenic Toxicity Studies".
All ICH parties have reached a scientific and technical consensus on this technical document, and issued and collected feedback.
Once this appendix is promulgated and implemented, it will be used together with ICH S1A "Guidelines for the Necessity of Drug Carcinogenic Toxicity Studies", S1B "Drug Carcinogenicity Tests" and S1C(R2) "Dose Selection for Drug Carcinogenic Toxicity Studies".
ICH S1B(R1) is currently in the second stage of guideline formulation.
All ICH parties have reached a scientific and technical consensus on this technical document, and issued and collected feedback.
Once this appendix is promulgated and implemented, it will be used together with ICH S1A "Guidelines for the Necessity of Drug Carcinogenic Toxicity Studies", S1B "Drug Carcinogenicity Tests" and S1C(R2) "Dose Selection for Drug Carcinogenic Toxicity Studies".
All ICH parties have reached a scientific and technical consensus on this technical document, and issued and collected feedback.
Once this appendix is promulgated and implemented, it will be used together with ICH S1A "Guidelines for the Necessity of Drug Carcinogenic Toxicity Studies", S1B "Drug Carcinogenicity Tests" and S1C(R2) "Dose Selection for Drug Carcinogenic Toxicity Studies".
According to the ICH guideline, “These changes to S1 introduce a more comprehensive and integrated approach to address the human carcinogenic risk of small molecule drugs.
According to the revised approach, it is not always necessary to conduct a two-year rat study.
The necessity of the research can be evaluated in specific cases to determine whether it is acceptable to use carcinogenicity evaluation instead of two-year research.
” The guide also discusses whether a 2-year rat carcinogenicity study on a given drug can increase the value of risk evaluation.
Clarification was provided for the decision criteria.
According to the revised approach, it is not always necessary to conduct a two-year rat study.
The necessity of the research can be evaluated in specific cases to determine whether it is acceptable to use carcinogenicity evaluation instead of two-year research.
” The guide also discusses whether a 2-year rat carcinogenicity study on a given drug can increase the value of risk evaluation.
Clarification was provided for the decision criteria.
According to the ICH guideline, “These changes to S1 introduce a more comprehensive and integrated approach to address the human carcinogenic risk of small molecule drugs.
According to the revised approach, it is not always necessary to conduct a two-year rat study.
The necessity of the research can be evaluated in specific cases to determine whether it is acceptable to use carcinogenicity evaluation instead of two-year research.
” The guide also discusses whether a 2-year rat carcinogenicity study on a given drug can increase the value of risk evaluation.
Clarification was provided for the decision criteria.
According to the revised approach, it is not always necessary to conduct a two-year rat study.
The necessity of the research can be evaluated in specific cases to determine whether it is acceptable to use carcinogenicity evaluation instead of two-year research.
” The guide also discusses whether a 2-year rat carcinogenicity study on a given drug can increase the value of risk evaluation.
Clarification was provided for the decision criteria.
The guidelines introduce a three-pronged "weight of evidence" method to evaluate whether the test compound may be carcinogenic, and whether the two-year rat study will bring greater value.
The guidelines introduce a three-pronged "weight of evidence" method to evaluate whether the test compound may be carcinogenic, and whether the two-year rat study will bring greater value.
The weight of evidence method is based on a comprehensive evaluation of data related to carcinogenic potential available from public sources and conventional drug development research, including:
The weight of evidence method is based on a comprehensive evaluation of data related to carcinogenic potential available from public sources and conventional drug development research, including:
1) The potential carcinogenicity data can be understood based on the drug target biology and the main pharmacological mechanism of the compound (including the carcinogenicity information of the drug category),
1) The potential carcinogenicity data can be understood based on the drug target biology and the main pharmacological mechanism of the compound (including the carcinogenicity information of the drug category),
2) The results of secondary pharmacological screening, especially those that can help understand the risk of cancer,
2) The results of secondary pharmacological screening, especially those that can help understand the risk of cancer,
3) Histopathological data of repeated dose toxicity studies completed with the test preparation, especially data focused on long-term rat studies (including exposure margin evaluation),
3) Histopathological data of repeated dose toxicity studies completed with the test preparation, especially data focused on long-term rat studies (including exposure margin evaluation),
4) Evidence of hormone perturbation,
4) Evidence of hormone perturbation,
5) Use ICH S2(R1) standard genetic toxicology research data,
5) Use ICH S2(R1) standard genetic toxicology research data,
6) Evidence of immune regulation carried out according to ICH S8
6) Evidence of immune regulation carried out according to ICH S8
ICH stated, “The application of this comprehensive approach will reduce the use of animals and follow the 3R (reduction, optimization, and replacement) principle.
While ensuring the safe development of new analyses and small molecules, it transfers resources to focus on a more scientifically based approach.
Mechanism of carcinogenicity evaluation.
"
While ensuring the safe development of new analyses and small molecules, it transfers resources to focus on a more scientifically based approach.
Mechanism of carcinogenicity evaluation.
"
ICH stated, “The application of this comprehensive approach will reduce the use of animals and follow the 3R (reduction, optimization, and replacement) principle.
While ensuring the safe development of new analyses and small molecules, it transfers resources to focus on a more scientifically based approach.
Mechanism of carcinogenicity evaluation.
"
While ensuring the safe development of new analyses and small molecules, it transfers resources to focus on a more scientifically based approach.
Mechanism of carcinogenicity evaluation.
"
The appendix of the guide also gives four case studies using the weight of evidence method to illustrate how to integrate the weight of evidence factors in determining the need for a 2-year rat study.
The four cases are: small molecule inhibitors for non-mammalian targets, neuron G protein-coupled receptor small molecule antagonists, ubiquitously expressed serine/threonine kinase pioneering small molecule inhibitors, and prostate receptor pioneering Small molecule inhibitors.
The four cases are: small molecule inhibitors for non-mammalian targets, neuron G protein-coupled receptor small molecule antagonists, ubiquitously expressed serine/threonine kinase pioneering small molecule inhibitors, and prostate receptor pioneering Small molecule inhibitors.
The appendix of the guide also gives four case studies using the weight of evidence method to illustrate how to integrate the weight of evidence factors in determining the need for a 2-year rat study.
The four cases are: small molecule inhibitors for non-mammalian targets, neuron G protein-coupled receptor small molecule antagonists, ubiquitously expressed serine/threonine kinase pioneering small molecule inhibitors, and prostate receptor pioneering Small molecule inhibitors.
The four cases are: small molecule inhibitors for non-mammalian targets, neuron G protein-coupled receptor small molecule antagonists, ubiquitously expressed serine/threonine kinase pioneering small molecule inhibitors, and prostate receptor pioneering Small molecule inhibitors.
Author: Zhilin-Lanshan
Author: Zhilin-Lanshan