Sách TK ngoại văn615.9(08)ICH Q1A (R2) Stability testing of new drug substances and drug products - Scientific guideline
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UDC
| 615.9(08) | |
Nhan đề
| ICH Q1A (R2) Stability testing of new drug substances and drug products - Scientific guideline | |
Mô tả vật lý
| 24tr. | |
Tóm tắt
| This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information to be submitted for abbreviated or abridged applications, variations and clinical trial applications. | |
Từ khóa tự do
| Chemical active substance | |
Từ khóa tự do
| Stability, stability testing | |
Địa chỉ
| Thư viện số Đại học Y Dược Thái Bình |
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000
| 00000nam#a2200000ui#4500 |
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| 001 | 64432 |
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| 002 | 12 |
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| 004 | A4ADC086-2FFD-4BE2-8031-DA4B8B0E1B63 |
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| 005 | 202603261647 |
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| 008 | 081223s2008 vm| vie |
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| 009 | 1 0 |
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| 039 | |y20260326164706|zthuoanh |
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| 080 | |a615.9(08) |
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| 245 | |aICH Q1A (R2) Stability testing of new drug substances and drug products - Scientific guideline |
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| 300 | |a24tr. |
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| 520 | |aThis document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information to be submitted for abbreviated or abridged applications, variations and clinical trial applications. |
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| 653 | |aChemical active substance |
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| 653 | |aStability, stability testing |
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| 852 | |aThư viện số Đại học Y Dược Thái Bình |
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