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European Medicines Agency September 1998
CAMP/ICH/363/96ICH Topic E 9
Statistical Principles for Clinical TrialsStep 5NOTE FOR GUIDANCE ON
STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
(CAMP/ICH/363/96)TRANSMISSION
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How to fill out cpmp ich 363 96
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What is cpmp ich 363 96?
CPMP ICH 363/96 is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the European Medicines Agency (EMA). It provides guidance on the investigation of drug interactions during clinical development of pharmaceuticals.
Who is required to file cpmp ich 363 96?
Any pharmaceutical company or organization conducting clinical trials or drug development studies is required to follow the guidelines outlined in CPMP ICH 363/96.
How to fill out cpmp ich 363 96?
To fill out CPMP ICH 363/96, pharmaceutical companies need to follow the specific recommendations provided in the guideline. It includes information on study design, data collection, analysis, and reporting of drug interactions during clinical development.
What is the purpose of cpmp ich 363 96?
The purpose of CPMP ICH 363/96 is to provide a standardized approach for the investigation of drug interactions during clinical development. It aims to ensure the safety and efficacy of pharmaceuticals by assessing potential interactions with other drugs.
What information must be reported on cpmp ich 363 96?
CPMP ICH 363/96 requires the reporting of detailed information related to the design, methodology, data analysis, and results of drug interaction studies conducted during clinical development. This includes information about the tested drugs, study population, study design, sampling, data analysis, and any observed drug interactions.
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