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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e7-studies-support-special-populations-geriatrics-questions-and-answers
The ICH guidance E7 Studies in Support of Special Populations: Geriatrics provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073131.pdf
Studies in Support of Special Populations: Geriatrics ICH-E7 August 1994. TABLE OF CONTENTS ... studies conducted exclusively in geriatric patients, at the sponsor's option.
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-7-studies-support-special-populations-geriatrics-step-5_en.pdf
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS ICH Harmonised Tripartite Guideline 1. STATEMENT OF PURPOSE It is important to ensure that clinical testing programs are carried out according to harmonised guidelines based on agreed ethical and scientific principles so …
https://www.ema.europa.eu/en/ich-e7-studies-support-special-populations-geriatrics
Older people, geriatrics, elderly, clinical trials: Description: This document provides guidance on the clinical evaluation of medicinal products in geriatric pupulations. It gives special consideration to the differences in pharmacokinetic, pharmacodynamic and dose response studies in elderly patients. It also covers drug drug interaction studies.
https://www.federalregister.gov/documents/2012/02/21/2012-3955/international-conference-on-harmonisation-guidance-on-e7-studies-in-support-of-special-populations
In the Federal Register of November 10, 2009 (74 FR 58024), FDA published a notice announcing the availability of a draft guidance entitled “E7 Studies in Support of Special Populations: Geriatrics Questions & Answers.” The notice gave interested persons an opportunity to submit comments by January 11, 2010.
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E7/Step4/E7_Guideline.pdf
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https://database.ich.org/sites/default/files/E7_Q%26As_Q%26As.pdf
E7 Geriatric Studies : Questions and Answers Date of Approval Questions Answers 3 Sept. 2009 Are there any special patient populations or characteristics that are particularly important to address in the planning of the clinical development program? Geriatric patients often have co …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4640010/
“Studies in Support of Special Populations: Geriatrics,” issued by ICH in 1994 urged clinical trial protocols to avoid arbitrary upper age limits. It also recommended not excluding elderly from trials even if they have other ailments, since doing so prevents uncovering interactions of multiple drugs or diseases.
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