When.com Web Search

Search results

1. Results From The WOW.Com Content Network

2. ICH Guidelines

   www.ich.org/page/ich-guidelines

   ICH Guidelines. The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories. Quality Guidelines.

3. ICH Official web site : ICH

   www.ich.org/page/quality-guidelines

   Quality Guidelines. Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

4. ICH Guidance Documents | FDA - U.S. Food and Drug Administration

   www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich...

   ICH E6: Good Clinical Practice: Consolidated Guidance (R2- Integrated Addendum) (PDF - 484 KB) Good Clinical Practice (GCP) is an international ethical and scientific quality standard for...

5. GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1)

   database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf

   ICH E8 provides an overall introduction to clinical development, designing quality into clinical studies and focusing on those factors critical to the quality of the studies. The guidelines should be considered and used in an integrated, holistic way rather than focusing on only one guideline or subsection.

6. ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3)

   database.ich.org/sites/default/files/ICH_E6(R3)_DraftGuideline_2023_0519.pdf

   9 The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual 10 acceptance of clinical trial data for ICH member countries and regions by applicable regulatory 11 authorities. 12 This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for 13 Clinical Studies.

7. ICH Official web site : ICH

   www.ich.org/products/guidelines.

   Electronic Standards (ESTRI) Reflection Papers & Discussion Groups. Consideration Documents. CIOMS Glossary of ICH Terms & Definitions. ICH PQKM Task Force. ICH Calendar. Assembly. Management Committee. ICH Public Events.

8. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

   www.fda.gov/media/93884/download

   This ICH GCP Guidance Integrated Addendum provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance

9. ANALYTICAL PROCEDURE DEVELOPMENT Q14

   database.ich.org/sites/default/files/ICH_Q14_Guideline_2023_1116.pdf

   This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products.

10. Quality Guidelines - ICH

    admin.ich.org/page/quality-guidelines

    Quality Guidelines. Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

11. ICH Official web site : ICH

    www.ich.org/products/guidelines.html

    ICH Guideline Database. Search tools are available for easy retrieval of information on ICH Guidelines: Index of ICH Guidelines by keyword, status and date; Status of Implementation of ICH Guidelines by ICH Members