It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. The purpose of this document is to offer a systematic approach to quality risk management. ICH Q9: Quality Risk Management (PDF - 113KB)
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This International Conference on Harmonization (ICH) guidance addresses the choice of control group in clinical trials, discussing five principal types of controls, two important purposes of clinical trials, and the issue of whether a trial could have detected a difference between treatments when there was a difference (assay sensitivity). ICH E10: Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB) This question and answer (Q&A) document is intended to clarify key issues. This ICH guidance provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that are likely to have significant use in the elderly. ICH E7: Studies in Support of Special Populations: Geriatrics Questions and Answers This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. ICH E6: Good Clinical Practice: Consolidated Guidance (R2- Integrated Addendum) (PDF - 484 KB) ICH E5 Questions and Answers (PDF - 48KB) This International Conference on Harmonization (ICH) document makes recommendations for strategies to permit clinical data collected in one region to be used to support drug and biologic registrations in another region while allowing for the influence of ethnic factors. ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB) ICH E3 Questions and Answers (PDF - 141KB)
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The guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review. This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.
ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF - 240KB)
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