List of Guidances for Statistics in Regulatory Affairs (English Wikipedia)
Analysis of information sources in references of the Wikipedia article "List of Guidances for Statistics in Regulatory Affairs" in English language version.
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eunethta.eu
- EUnetHTA - Endpoints used for Relative Effectiveness Assessment Clinical Endpoints Amended JA1 Guideline Final Nov 2015
- EUnetHTA - Endpoints used for Relative Effectiveness Assessment Composite endpoints Amended JA1 Guideline Final Nov 2015
- EUnetHTA - Endpoints used in Relative Effectiveness Assessment Surrogate Endpoints Amended JA1 Guideline Final Nov 2015
- EUnetHTA - Endpoints used in Relative Effectiveness Assessment Safety Amended JA1 Guideline Final Nov 2015
- EUnetHTA - Endpoints used for Relative Effectiveness Assessment Health related quality of life and utility measures Amended JA1 Guideline Final Nov 2015
- EUnetHTA - Comparators & Comparisons Criteria for the choice of the most appropriate comparator(s) Amended JA1 Guideline 2015
- EUnetHTA - Comparators & Comparisons Direct and indirect comparisons Amended JA1 Guideline Final Nov 2015
europa.eu
ema.europa.eu
- CHMP/EWP/5872/03 Data monitoring committees
- EMA/CHMP/295050/2013 Adjustment for baseline covariates in clinical trials
- CHMP/EWP/83561/05 Clinical trials in small populations
- EMA/199678/2016 Reflection paper on extrapolation of efficacy and safety in paediatric medicine development (PDF), European Medicines Agency (EMA), 2017
- EMA/189724/2018 Reflection paper on the use of extrapolation in the development of medicines for paediatrics, European Medicines Agency (EMA), 2018
- EMA/129698/2012 Concept paper on extrapolation of efficacy and safety in medicine development, European Medicines Agency (EMA), 2013
- CPMP/EWP/2158/99 Choice of a non-inferiority margin
- CPMP/EWP/482/99 Switching between superiority and non-inferiority
- EMA/CHMP/539146/2013 Investigation of subgroups in confirmatory clinical trials
- CPMP/EWP/2330/99 Application with 1. Meta-analyses; 2. One pivotal
- EMA/129698/2012 Extrapolation of efficacy and safety in medicine development
- CPMP/EWP/1776/99 Missing data in confirmatory clinical trials
- EMA/286914/2012 Multiplicity issues in clinical trials
- CHMP/EWP/2459/02 Methodological issues in confirmatory clinical trials planned with an adaptive design
- EMA - Guideline on bioanalytical method validation
- EMA/CHMP/483572/2012 Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD) (PDF), European Medicines Agency (EMA), Respiratory Drafting Group, 2012
- EMA/CHMP/771815/2011, Rev 2 - Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis (PDF), European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), 2015
fda.gov
- FDA - Good Review Practice: Clinical Review of Investigational New Drug Applications
- FDA - Establishment and Operation of Clinical Trial Data Monitoring Committees
- Rare diseases: Common issues in drug development. Guidance for industry. (PDF), U.S. Department of Health and Human Services; Food and Drug Administration, 2015
- Leveraging existing clinical data for extrapolation to pediatric uses of medical devices (PDF), U.S. Department of Health and Human Services; Food and Drug Administration, 2016
- Use of real-world evidence to support regulatory decision-making for medical devices (PDF), U.S. Department of Health and Human Services; Food and Drug Administration, 2017
- FDA - Clinical trial endpoints for the approval of cancer drugs and biologics
- FDA-2016-D-4460: Multiple Endpoints in Clinical Trials. Guidance for Industry.
- FDA - Safety Reporting Requirements for INDs and BA/BE Studies
- FDA - Adverse Event Reporting to IRBs
- FDA - Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
- FDA - Adaptive Design Clinical Trials for Drugs and Biologics
- "Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials". U.S. Department of Health and Human Services Food and Drug Administration Office of the Commissioner. October 2008. Retrieved 24 August 2022.
This article incorporates text from this source, which is in the public domain. - FDA - Evaluation of Sex-Specific Data in Medical Device Clinical Studies
- FDA - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
ich.org
- ICH E6(R2) - Good clinical practice (GCP)
- Ethnic factors in the acceptability of foreign clinical data, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1998
- ICH E1 - Population exposure: the extent of population exposure to assess clinical safety
- ICH E3 - Structure and content of clinical study reports
- ICH E2F - Development Safety Update Report
- ICH E4 - Dose response information to support drug registration
- ICH E5 (R1)- Ethnic factors in the acceptability of foreign clinical data
- ICH E9 - Statistical Principles for Clinical Trials
- ICH E10 - Choice of control group in clinical trials
- ICH E7 - Studies in support of special populations: geriatrics
iqwig.de
- Allgemeine Methoden (General methods), version 5.0, Cologne, Germany: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG; Institute for Quality and Efficiency in Health Care), 10 July 2017, ISBN 978-3-9815265-2-3