September, 2013

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Brave New Biopharm Blogging

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Although a few articles on this site are older, I really only began blogging in earnest about 15 months ago. However, I suppose that's long enough that I can count myself as at least somewhat established, and take a moment to welcome and encourage some interesting newcomers to the scene. Bloggers in dank basements their natural habitat. There are 3 relative newcomers that I've found really interesting, all with very different perspectives on drug development and clinical research: Pharmagellan T

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Questionable Enrollment Math(s) - the Authors Respond

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The authors of the study I blogged about on Monday were kind enough to post a lengthy comment, responding in part to some of the issues I raised. I thought their response was interesting, and so reprint it in its entirety below, interjecting my own reactions as well. There were a number of points you made in your blog and the title of questionable maths was what caught our eye and so we reply on facts and provide context.

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Questionable Enrollment Math at the UK's NIHR

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There has been considerable noise coming out of the UK lately about successes in clinical trial enrollment. First, a couple months ago came the rather dramatic announcement that clinical trial participation in the UK had " tripled over the last 6 years ". That announcement, by the chief executive of the Sweet creature of bombast: is Sir John writing press releases for the NIHR?

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Every Unhappy PREA Study is Unhappy in its Own Way

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“Children are not small adults.” We invoke this saying, in a vague and hand-wavy manner, whenever we talk about the need to study drugs in pediatric populations. It’s an interesting idea, but it really cries out for further elaboration. If they’re not small adults, what are they? Are pediatric efficacy and safety totally uncorrelated with adult efficacy and safety?

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud