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This paper is about the use of 0, and is proposed for use in drug development and marketing authorization applications. It was also prepared to comment on the relationship between the two and the other. Whilst in some parts the paper describes Frequentists statistical methods, the field is also open to explore alternative approaches, eg following the Bayesian methodology.

The current document does not contain any explicit explanations. It rather tries to establish a framework and a common language to facilitate the dialogue between stakeholders.

The content of this discussion paper and its implications will be discussed at a European Medicines Agency's public work shop at the end of the 12-month public consultation phase. A longer than usual EMA via interaction with the Scientific Advice Working Group.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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