ºÝºÝߣshows by User: JunBrown / http://www.slideshare.net/images/logo.gif ºÝºÝߣshows by User: JunBrown / Sun, 03 May 2015 22:26:29 GMT ºÝºÝߣShare feed for ºÝºÝߣshows by User: JunBrown Comparison of stability testing requirements of ich with other /slideshow/comparison-of-stability-testing-requirements-of-ich-with-other/47711162 comparisonofstabilitytestingrequirementsofichwithother-150503222629-conversion-gate02
Stability plays an important role in the drug development process. Present work aims to compare the stability testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability testing requirements for new drug substance and drug product. WHO guidelines describe stability testing requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information to be submitted in original and subsequent applications for marketing authorization of their related Finished pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term storage condition (general case) and accelerated storage conditions (substance/product intended to be stored in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on stability testing requirements for new active substance and related products. It sets out the stability testing requirements for existing active substance and related finished product. The minimum time period to be covered by data at the time of submission during long term storage conditions differs from ICH guidelines.]]>
Stability plays an important role in the drug development process. Present work aims to compare the stability testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability testing requirements for new drug substance and drug product. WHO guidelines describe stability testing requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information to be submitted in original and subsequent applications for marketing authorization of their related Finished pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term storage condition (general case) and accelerated storage conditions (substance/product intended to be stored in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on stability testing requirements for new active substance and related products. It sets out the stability testing requirements for existing active substance and related finished product. The minimum time period to be covered by data at the time of submission during long term storage conditions differs from ICH guidelines.]]> Sun, 03 May 2015 22:26:29 GMT /slideshow/comparison-of-stability-testing-requirements-of-ich-with-other/47711162 JunBrown@slideshare.net(JunBrown) Comparison of stability testing requirements of ich with other JunBrown Stability plays an important role in the drug development process. Present work aims to compare the stability testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability testing requirements for new drug substance and drug product. WHO guidelines describe stability testing requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information to be submitted in original and subsequent applications for marketing authorization of their related Finished pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term storage condition (general case) and accelerated storage conditions (substance/product intended to be stored in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on stability testing requirements for new active substance and related products. It sets out the stability testing requirements for existing active substance and related finished product. The minimum time period to be covered by data at the time of submission during long term storage conditions differs from ICH guidelines. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/comparisonofstabilitytestingrequirementsofichwithother-150503222629-conversion-gate02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Stability plays an important role in the drug development process. Present work aims to compare the stability testing (ST) requirements of International Conference on Harmonization (ICH) with other international regulatory agencies like World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA). ICH guidelines describe stability testing requirements for new drug substance and drug product. WHO guidelines describe stability testing requirements for both new and existing Active pharmaceutical ingredients (APIs) and addresses information to be submitted in original and subsequent applications for marketing authorization of their related Finished pharmaceutical products (FPP) for human use. ST requirements for WHO are similar, except for the parameters like selection of batches and storage conditions. WHO guidelines have an additional requirement for long term storage condition (general case) and accelerated storage conditions (substance/product intended to be stored in refrigerator). ASEAN guideline mainly focuses on the requirements for stability testing of drug products along with new chemical entities (NCE’s). The differences were observed in stress testing, selection of batches and real time storage conditions. EMEA guidelines discussed here are an extension of the note for guidance on stability testing requirements for new active substance and related products. It sets out the stability testing requirements for existing active substance and related finished product. The minimum time period to be covered by data at the time of submission during long term storage conditions differs from ICH guidelines.
Comparison of stability testing requirements of ich with other from Jun Brown
]]> 4685 6 https://cdn.slidesharecdn.com/ss_thumbnails/comparisonofstabilitytestingrequirementsofichwithother-150503222629-conversion-gate02-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://public.slidesharecdn.com/v2/images/profile-picture.png