Medical Writing Artificial Intelligence and Machine Learning Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics
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Volume 32, Issue 3 - Artificial Intelligence and Machine Learning

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics

Abstract

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory assessment. Reporting M&S analyses can be technically challenging given the large amount of input and output data that need to be summarised and accurately described in regulated reports. Therefore, reproducibility, automation, traceability, and standardisation are considered key aspects of this process. We present here a system that, using a combination of software, meets these challenges and improves the efficiency, accuracy, and reliability of our work.

Medical Writing. 2023;32(3):56–63. https://doi.org/10.56012/wmqy8556

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Raquel Billiones

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Evguenia Alechine

Jonathan Pitt

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Victoria White

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Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

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Daniela Kamir

AI/Automation

Jennifer Bell

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Nicole Bezuidenhout 

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Somsuvro Basu

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Ana Sofia Correia 

Gained in Translation

Ivana Turek

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Wendy Kingdom / Amy Whereat

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Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

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Lisa Chamberlain-James

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Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

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Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

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Elise Langdon-Neuner

Phil Leventhal

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Chris Monk