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UDC
| 615.9(08) | |
Nhan đề
| Asean stability guideline (version 6.0) | |
Mô tả vật lý
| 43tr. | |
Tóm tắt
| This document provides guidelines for stability studies of drug products, including objectives, scope, design considerations, testing parameters, storage conditions, evaluation, and reporting requirements. Key aspects covered include testing at least three primary batches of new chemical entities and two batches of generics, analyzing physical, chemical, and microbiological attributes, storing products under various conditions like room temperature and refrigeration, evaluating data at multiple time points, and committing to a shelf life. The guidelines aim to ensure drug products maintain quality, safety and efficacy throughout their proposed shelf life. | |
Từ khóa tự do
| Generics, analyzing physical, chemical, and microbiological attributes | |
Từ khóa tự do
| Quality, safety and efficacy throughout their proposed shelf life. | |
Địa chỉ
| Thư viện số Đại học Y Dược Thái Bình |
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| 00000nam#a2200000ui#4500 |
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| 001 | 64431 |
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| 002 | 12 |
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| 004 | 32A7FA56-59F9-4301-A430-6487F80A3D54 |
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| 005 | 202603261640 |
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| 008 | 081223s2026 vm| vie |
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| 009 | 1 0 |
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| 039 | |y20260326164022|zthuoanh |
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| 080 | |a615.9(08) |
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| 245 | |aAsean stability guideline (version 6.0) |
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| 300 | |a43tr. |
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| 520 | |aThis document provides guidelines for stability studies of drug products, including objectives, scope, design considerations, testing parameters, storage conditions, evaluation, and reporting requirements. Key aspects covered include testing at least three primary batches of new chemical entities and two batches of generics, analyzing physical, chemical, and microbiological attributes, storing products under various conditions like room temperature and refrigeration, evaluating data at multiple time points, and committing to a shelf life. The guidelines aim to ensure drug products maintain quality, safety and efficacy throughout their proposed shelf life. |
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| 653 | |aGenerics, analyzing physical, chemical, and microbiological attributes |
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| 653 | |aQuality, safety and efficacy throughout their proposed shelf life. |
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| 852 | |aThư viện số Đại học Y Dược Thái Bình |
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