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Health ministry releases 9th edition of IP containing 3,152 monographs

AuroBlog - Aurous Healthcare Clinical Trials blog

With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution (..)

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Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients

Pharma Times

The platform delivers digitalised patient data to improve clinical trials and development

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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective 

Pharmaceutical Technology

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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March 23, 2023: AJOB Calls for Peer Commentaries on Ethics in Pragmatic Trials

Rethinking Clinical Trials

The American Journal of Bioethics ( AJOB ) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core.

Trials 189
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Clinical Trial Kitting: Avoid Costly Pitfalls

Imperical Blog

Clinical trial kits, which contain necessary items for site visits like sample tubes, labels, and instructions, all conveniently customized by trial and visit, are a staple of clinical trials. On the surface, putting the kits together might seem simple enough, but it’s not.

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Rival radiopharma drug to Novartis’ Lutathera succeeds in trial, ITM says

Bio Pharma Dive

ITM's lutetium-containing therapy extended progression-free survival versus everolimus in patients with a specific kind of neuroendocrine tumor.