Patient Recruitment Driving Length and Cost of Oncology Clinical Trials

Jun 27, 2013

As prospective oncology drugs progress from Phase I to Phase III clinical trials, the difference between projected and actual patient enrollment durations typically increases. In most cases, oncology clinical trial delays are a direct result of patient recruitment challenges.  This is particularly true when multiple companies run competing clinical trials. Adam Bianchi, Ryan McGuire & Rochelle Gagg at Cutting Edge Info, analyses the two main factors impacting duration are the level of difficulty of trial-specific patient recruitment and the number of patient visits required by a trial. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/2-Patient-Recruitment-Driving-Lenght-and-Cost-of-Oncology-Clinical-Trials.pdf” type=”pdf”]Patient Recruitment Driving Lenght and Cost of Oncology Clinical Trials[/prettyfilelink] ...

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Photostability Testing: Shedding Light on a Not Well Understood Guideline

Jun 27, 2013

The subject of pharmaceutical photostability testing often raises many questions for several reasons. Predominantly governed by ICH Guideline Q1B for small molecules, or ICH Q5C for biotechnology products, the standards are not particularly well written and often cause confusion. Q1B, in particular, provides options to use two non-equivalent light sources and additional variants. The standard also mixes radiometric and photometric light measurements for the ultraviolet and visible light dosages. Allen Zielnik at Atlas Material Testing Technology LLC explains the guideline options available, and provides some practical guidance. [prettyfilelink src=”http://ipimediaworld.com/wp-content/uploads/2013/06/1-Photostability-Testing-Shedding-Light-on-a-Not-Well-Understood-Guideline.pdf” type=”pdf”]Photostability Testing Shedding Light on a Not Well Understood Guideline[/prettyfilelink] ...

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