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Journal for Clinical Studies
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Category Archives: Volume 11 Issue 3

FDA Attempting to Address Unmet Needs for Patients with Brain Metastases

Volume 11 Issue 3By flabio517th June 2019Leave a comment

Molly Fellin Spence of Clarivate discusses the FDA’s efforts towards advancing the development of products for CNS metastases, where effective…

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Academic Collaboration with Contract Research Organisations: Reaching Out to the Right Expertise at the Right Time

Volume 11 Issue 3By flabio517th June 2019Leave a comment

Drug discovery and development, while usually a role of the pharmaceutical industry, is a long, difficult and expensive process, which…

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Providing Regulatory Clarity for Cell- and Gene-based Therapies

Volume 11 Issue 3By flabio517th June 2019Leave a comment

Adam Istas, DIA explores how global regulators are responding to dramatic increases in cell and gene-based products in development. Regulators…

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What Can LOINC Do for SDTM?

Volume 11 Issue 3By flabio517th June 2019Leave a comment

LOINC is an internationally recognized classification system and is often requested in regulatory data submissions to provide context to clinical…

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Modelling and Simulation is Key to Modern Drug Development

Volume 11 Issue 3By flabio517th June 2019Leave a comment

The FDA has been promoting innovative and disruptive approaches towards modernizing drug development and clinical trials, which the industry has…

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Clinical Evaluation & Post-marketing Surveillance of Medical Devices in Singapore

Volume 11 Issue 3By flabio517th June 2019Leave a comment

Dr Balamuralidhara V. et al of the JSS College of Pharmacy present a study which examines the clinical evaluation and…

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How Engaging Patients in Trial Design Maximises Orphan Drug Success

Volume 11 Issue 3By flabio517th June 2019Leave a comment

Orphan drug discovery presents both opportunities and challenges, with research in this space having some of the highest hurdles in…

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Drug Delivery to the Eye: The Challenges and Opportunities of Drug Delivery Through a Complex Barrier

Volume 11 Issue 3By flabio517th June 2019Leave a comment

Eye health and vision has a major impact on the quality of life, and as such the development of products…

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Clinical Research in Rare Diseases: Adult Onset Still’s Disease

Volume 11 Issue 3By flabio517th June 2019Leave a comment

Adult onset Still’s disease (AOSD) is a rare inflammatory joint disease of unknown aetiology, characterised by arthritis, fevers spiking once…

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The Case for Response Adaptive Trial Design for Rare Diseases

Volume 11 Issue 3By flabio517th June 2019Leave a comment

With 7,000 rare diseases affecting 350 million people worldwide, Holly Jackson at Quanticate identifies how businesses exploring rare diseases can…

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