Medical Writing Generics and biosimilars Journal Watch
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Volume 28, Issue 2 - Generics and biosimilars

Journal Watch

Abstract

Journal Watch is based on the French language blog, Rédaction Médicale et Scientifique, by Hervé Maisonneuve, available at www.redactionmedicale.fr.

References

  1. Freeling B, Doubleday ZA, Connell SD. How can we boost the impact of publications? Try better writing. PNAS. 2019;116(2):341 43.
  2. Amrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature. 2019;567:305 7.
  3. Ioannidis JPA. The importance of predefined rules and prespecified statistical analyses: Do not abandon significance. JAMA Published online April 4, 2019. doi:10.1001/jama.2019.4582
  4. Broderick NA, Casadevall A. Gender inequalities among authors who contributed equally. eLife 2019;8:e36399.
  5. Fox CW, Paine CET. Gender differences in peer review outcomes and manuscript impact at six journals of ecology and evolution. Ecol Evol. 2019;00:1–21.
  6. Wickman C, Fitzgerald E. Writing and science: An editorial perspective. Written Communication. 2019, Vol. 36(1) 3–8.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

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Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: