Formulations in early clinical development require a delicate balance of flexibility, simplicity, and scientific rigor. In first‑in‑human trials, dose ranges can vary by 10–100 fold increase between the starting dose a...
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The Significant Role of a Robust Regulatory Intelligence Process in Global Safety Submissions
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety, written by Arinder Sihota and Trupti Gurjar, which featured in the March 2020 edition of Pharma Focus.
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The Promise of IoMT
A thought leadership article authored by David Novotny and Marie McCarthy, which focuses on the advances in connected devices such as wearable biosensors and mobile trackers.
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Best Practices in Seasonal Vaccine Efficacy Studies: Tips for Successful Planning and Execution
A thought leadership piece by Cindy Dukes exploring the unique challenges in planning and executing a seasonal vaccine study.
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Is Pharma Finally Heading for Launch Excellence?
The traditional approaches to launching a new medicine still tend to sit in the commercial function, but they need to better align with HEOR, medical affairs and clinical teams. Read more in the February issue of PME.
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Keeping it Real: Challenges and Benefits of Integrating AI and Machine Learning into Pharma R&D
ICON's CIO Tom O'Leary provides expert commentary on integrating AI and machine learning into Pharma R&D in this January 2020 Bio IT World Article.
