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Notice on holding the ICH Q8(R2)-Q12 Guidelines Online Training
Time of Update: 2023-01-05
Notice on holding the ICH Q8(R2)-Q12 Guidelines Online TrainingRelease date: 20221125 In order to further promote the understanding and mastery of domestic reviewers and industry of the technical req
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The results of the 6-year follow-up of the RELEVANCE study are announced! Can R2 surpass R-chemo in patients with follicular lymphoma?
Time of Update: 2022-10-14
Results of the study Baseline characteristics From December 2011 to November 2014, a total of 1030 patients were randomly assigned 1:1 to receiveR2 (n=513) or R-chemo (n=517), respectively, with similar baseline characteristics in both groups (Table 1).
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Staging System for Total Survival of Multiple Myeloma (R2-ISS).
Time of Update: 2022-10-01
In the subgroup of cytogenetically high-risk patients with revision of 1q+, the MRD negative rate in the D-VRd group after consolidation therapy, after 12 months of maintenance therapy, and 24 months after maintenance therapy was significantly higher than that in the VRd treatment group.
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CDE publishes ICH "Q2(R2): Analytical Method Validation" and "Q14: Analytical Method Development" guidelines for comments
Time of Update: 2022-10-01
Source: CDE websiteThe ICH Guiding Principles for Q2(R2): Validation of Analytical Methods and Q14: Development of Analytical Methods are now in Phase 3 Regional Public Comment Phase. In accordance wi
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Notice of Public Solicitation of Recommendations for the Implementation of the ICH Q3D(R2
Time of Update: 2022-09-20
Q3D (R2) English version Drug Evaluation Center of the State Drug Administration September 8, 2022 In order to promote the smooth implementation of the newly revised ICH guidelines in China, our center has formulated the implementation recommendations of "Q3D (R2): Guiding Principles for Elemental Impurities" and organized the translation of Chinese version.
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of the application of R2-CHOP regimen to effectively treat rare four-strike polymorphic mantle cell lymphoma
Time of Update: 2022-01-09
Figure 2 Morphology and immunophenotype of quadruple-strike pleomorphic MCL: Lymphoma cells have pleomorphic morphology (A) and express CD20 (B), BCL2 (C), BCL6 (D), Cyclin D1 (E) , MYC (F), CD21 (G), P53 (H), and have a high Ki67 index (I) In view of the overexpression of BCL6, MYC, Cyclin D1 and BCL2, interphase fluorescence in situ hybridization of these related genes ( FISH) analysis .
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Notice on Public Solicitation of ICH Guiding Principles "M7(R2)"
Time of Update: 2021-12-24
See the attachment for the original text and Chinese translation of M7 (R2).
M7 (R2) appendix Chinese translation ICH work office December 21, 2021 Relevant attachments Serial number accessory name 1 English text of M7(R2).
docx 4 M7(R2) appendix Chinese translation.
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CDE publicly solicits opinions on M7 (R2) related ICH guidelines
Time of Update: 2021-12-24
On December 21, CDE issued an announcement stating that the ICH guideline "M7 (R2): Assessment and Control of Active DNA (Mutogenic) Impurities in Drugs to Limit Potential Carcinogenic Risks" is now in the third stage for comments .
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2021 EHA Voice of China Professor Zhou Daobin's team new progress: R2-MTX regimen for the treatment of newly diagnosed PCNSL
Time of Update: 2021-06-22
Abstract Number: S223 Title: Phase IB/II Study: Combination therapy of lenalidomide, rituximab, and high-dose methotrexate (R2-MTX), followed by lenalidomide maintenance treatment for newly diagnosed primary central nervous system Systematic lymphoma research method This is a multi-center, prospective phase Ib/II study (NCT04120350) .
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MD Anderson Cancer Center announces long-term follow-up results of R2 regimen in the treatment of follicular lymphoma
Time of Update: 2021-03-24
Although the primary endpoint of the study was progression-free survival (PFS), due to the limited median follow-up time (3 years) in the study, the main efficacy index (complete remission at 30 months [CR]) was reported at the end of the study.
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Notice of a questionnaire survey on the revision of the ICH E6 (R2) Code of Practice for Drug Clinical Trials
Time of Update: 2020-05-15
November 2016, ICH issued a "comprehensive appendix of E6 (R1): The trials of drug quality management practices E6 (R2)" (hereinafter referred to as E6 (R2)) But since E6 (R2) formulation, clinical tr