Medical Writing Generics and biosimilars My First Medical Writing
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Volume 28, Issue 2 - Generics and biosimilars

My First Medical Writing

Abstract

In this release of My First Medical Writing, we welcome one of the first articles written by Robin Sachdeva. Robin finished his PhD at Heidelberg University in Germany, and he is passionate about reading and writing about diabetes. Fortunately, since we started working together on this article, he transitioned from being an “aspiring medical writer” to being hired as a research scientist in Canada. He is now involved in designing clinical trials, preparing comprehensive final reports, and writing manuscripts. It has been a great pleasure to share this journey with him, seeing him grow in his writing skills, and now publishing his first article in Medical Writing.

References

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  2. Marin-Penalver JJ, Martin-Timon I, Sevillano-Collantes C, Del Canizo-Gomez FJ. Update on the treatment of type 2 diabetes mellitus. World Journal of Diabetes. 2016; 7:354–95.
  3. Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al. E.mpagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117–28.
  4. Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet. 2019;393:31–9.
  5. Lee G, Oh SW, Hwang SS, Yoon JW, Kang S, Joh HK, et al. Comparative effectiveness of oral antidiabetic drugs in preventing cardiovascular mortality and morbidity: A network meta-analysis. PLoS One. 2017;12:e0177646.
  6. Stenlof K, Cefalu WT, Kim KA, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15:372–82.
  7. Pinto LR, Rados DV, Remonti LR, Kramer CK, Leitao CB, Gross JL Efficacy of SGLT2 inhibitors in glycaemic control, weight loss and blood pressure reduction: a systematic review and meta-analysis. Diabetol Metab Syndr. 2015;7(Suppl 1):A58.
  8. Modi A, Agrawal A, Morgan F. Euglycemic diabetic ketoacidosis: a review. Curr Diabetes Rev. 2017;13:315–21.
  9. Wu JH, Foote C, Blomster J, et al. Effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular events, death, and major safety outcomes in adults with type 2 diabetes: a systematic review and metaanalysis. Lancet Diabetes Endocrinol. 2016;4:411–9.
  10. Marín-Peñalver JJ, Martín-Timón I, Sevillano-Collantes C, Del Cañizo-Gómez FJ, Update on the treatment of type 2 diabetes mellitus. World J Diabetes. 2016;7:354–95.
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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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