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	<title>Ask The Experts</title>
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	<link>http://randd.canon-experts.com</link>
	<description>The only place to get expert advice!</description>
	<pubDate>Mon, 31 May 2230 14:18:52 +0000</pubDate>
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			<item>
		<title>How do you get an accurate baseline QT measurement and still take increased heart rate into account?</title>
		<link>http://randd.canon-experts.com/2230/05/2how-do-you-get-an-accurate-baseline-qt-measurement-and-still-take-increased-heart-rate-into-account/</link>
		<comments>http://randd.canon-experts.com/2230/05/2how-do-you-get-an-accurate-baseline-qt-measurement-and-still-take-increased-heart-rate-into-account/#comments</comments>
		<pubDate>Mon, 31 May 2230 14:18:46 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Alan Copa, PharmD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=267</guid>
		<description><![CDATA[It is possible to get an accurate baseline QT measurement, while taking the increased heart rate into account. One solution we have implemented is including exercise as part of the baseline ECG collection. 
 
In our experience conducting thorough QT studies, the use of treadmills can mimic the increased heart rate levels that the compound is [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2230/05/2how-do-you-get-an-accurate-baseline-qt-measurement-and-still-take-increased-heart-rate-into-account/feed/</wfw:commentRss>
		</item>
		<item>
		<title>What are the most critical elements in designing a thorough QT trial?</title>
		<link>http://randd.canon-experts.com/2230/05/1what-are-the-most-critical-elements-in-designing-a-thorough-qt-trial/</link>
		<comments>http://randd.canon-experts.com/2230/05/1what-are-the-most-critical-elements-in-designing-a-thorough-qt-trial/#comments</comments>
		<pubDate>Mon, 31 May 2230 14:17:44 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Alan Copa, PharmD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=263</guid>
		<description><![CDATA[Regardless of your approach to thorough QT trials, key elements that must always be considered in study design include: 
·         Parallel or crossover – Dependent on the half-life of the drug or population under evaluation, parallel or crossover study designs must be considered. 
·         Number of subjects – Subject numbers can be determined by the [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2230/05/1what-are-the-most-critical-elements-in-designing-a-thorough-qt-trial/feed/</wfw:commentRss>
		</item>
		<item>
		<title>You mentioned patient adherence, which is currently a topic of major interest within the pharmaceutical industry.  Can you briefly touch on some of the more successful patient support services you are aware of that address the challenge of patient adherence?</title>
		<link>http://randd.canon-experts.com/2012/05/successful-patient-support-services/</link>
		<comments>http://randd.canon-experts.com/2012/05/successful-patient-support-services/#comments</comments>
		<pubDate>Mon, 07 May 2012 18:24:30 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Scott Dulitz, MBA]]></category>

		<category><![CDATA[clinical trials]]></category>

		<category><![CDATA[home nursing support]]></category>

		<category><![CDATA[medication management]]></category>

		<category><![CDATA[patient adherence]]></category>

		<category><![CDATA[patient support programs]]></category>

		<category><![CDATA[pharmacy benefit manager]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=293</guid>
		<description><![CDATA[The best adherence programs have customization within the program patient level which contains data driven, drug interaction and customization info from a pharmacy benefit manager. ]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2012/05/successful-patient-support-services/feed/</wfw:commentRss>
		</item>
		<item>
		<title>How do you see pharmaceutical manufacturer-sponsored patient support programs evolving over the next few years?</title>
		<link>http://randd.canon-experts.com/2012/05/how-do-you-see-pharmaceutical-manufacturer-sponsored-patient-support-programs-evolving-over-the-next-few-years/</link>
		<comments>http://randd.canon-experts.com/2012/05/how-do-you-see-pharmaceutical-manufacturer-sponsored-patient-support-programs-evolving-over-the-next-few-years/#comments</comments>
		<pubDate>Thu, 03 May 2012 13:47:29 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Scott Dulitz, MBA]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=290</guid>
		<description><![CDATA[In an effort to improve patient adherence many programs are now also experimenting with social media and other electronic communication platforms such as secure email and text messages. ]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2012/05/how-do-you-see-pharmaceutical-manufacturer-sponsored-patient-support-programs-evolving-over-the-next-few-years/feed/</wfw:commentRss>
		</item>
		<item>
		<title>What considerations should be given to the collection of multiple measurements at the same time points?</title>
		<link>http://randd.canon-experts.com/2011/05/what-considerations-should-be-given-to-the-collection-of-multiple-measurements-at-the-same-time-points/</link>
		<comments>http://randd.canon-experts.com/2011/05/what-considerations-should-be-given-to-the-collection-of-multiple-measurements-at-the-same-time-points/#comments</comments>
		<pubDate>Tue, 31 May 2011 18:42:28 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Alan Copa, PharmD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=278</guid>
		<description><![CDATA[In Cetero’s experience, when multiple measurements are to be collected at the same time point, the order of activities should be:
1.    Holter ECG acquisition
2.    PK sample collection
3.    Vital sign measurement
Priority should be given to the collection of the triplicate ECGs from the Holter device because of the amount of time required for the supine resting [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2011/05/what-considerations-should-be-given-to-the-collection-of-multiple-measurements-at-the-same-time-points/feed/</wfw:commentRss>
		</item>
		<item>
		<title>What role does calculating the supratherapeutic dose for a central nervous system compound delivered orally play in study timelines?</title>
		<link>http://randd.canon-experts.com/2011/05/what-role-does-calculating-the-supratherapeutic-dose-for-a-central-nervous-system-compound-delivered-orally-play-in-study-timelines/</link>
		<comments>http://randd.canon-experts.com/2011/05/what-role-does-calculating-the-supratherapeutic-dose-for-a-central-nervous-system-compound-delivered-orally-play-in-study-timelines/#comments</comments>
		<pubDate>Tue, 31 May 2011 18:41:45 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Alan Copa, PharmD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=276</guid>
		<description><![CDATA[A central nervous system compound may require dose titration in order for the dose to be tolerated and to achieve a suprathereapeutic dose. Titration will require multiple doses over multiple days and in some cases, depending on the compound, may require more than 28 days to achieve the supratherapeutic dose. Even with careful dose titration, [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2011/05/what-role-does-calculating-the-supratherapeutic-dose-for-a-central-nervous-system-compound-delivered-orally-play-in-study-timelines/feed/</wfw:commentRss>
		</item>
		<item>
		<title>What additional factors need to be considered when an intravenous or injectable delivery method is used in a TQT trial?</title>
		<link>http://randd.canon-experts.com/2011/05/what-additional-factors-need-to-be-considered-when-an-intravenous-or-injectable-delivery-method-is-used-in-a-tqt-trial/</link>
		<comments>http://randd.canon-experts.com/2011/05/what-additional-factors-need-to-be-considered-when-an-intravenous-or-injectable-delivery-method-is-used-in-a-tqt-trial/#comments</comments>
		<pubDate>Tue, 31 May 2011 18:41:02 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Alan Copa, PharmD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=273</guid>
		<description><![CDATA[Intravenous (IV) or injection delivery in a TQT study requires extra preparation to ensure successful study conduct.
•    Dose administration with an intravenous infusion requires planning to consistently deliver the dose over the defined time interval. Based on Cetero’s experience, we recommend filling empty IV bags with the appropriate volume of diluent and drug. This practice [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2011/05/what-additional-factors-need-to-be-considered-when-an-intravenous-or-injectable-delivery-method-is-used-in-a-tqt-trial/feed/</wfw:commentRss>
		</item>
		<item>
		<title>When determining the supratherapeutic dose, what are the most critical steps?</title>
		<link>http://randd.canon-experts.com/2011/05/when-determining-the-supratherapeutic-dose-what-are-the-most-critical-steps/</link>
		<comments>http://randd.canon-experts.com/2011/05/when-determining-the-supratherapeutic-dose-what-are-the-most-critical-steps/#comments</comments>
		<pubDate>Tue, 31 May 2011 18:40:17 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Alan Copa, PharmD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=271</guid>
		<description><![CDATA[Defining the supratherapeutic dose is dependent on the investigational compound. Because of this, it is essential that you:
•    Know as much as possible about the compound. It is ideal if the maximum tolerated dose (MTD) has been defined. If an MTD has not been identified, a compilation of the adverse events observed during past studies, [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2011/05/when-determining-the-supratherapeutic-dose-what-are-the-most-critical-steps/feed/</wfw:commentRss>
		</item>
		<item>
		<title>Can you explain the logistical challenges of staggered dosing across cohorts?</title>
		<link>http://randd.canon-experts.com/2010/12/can-you-explain-the-logistical-challenges-of-staggered-dosing-across-cohorts/</link>
		<comments>http://randd.canon-experts.com/2010/12/can-you-explain-the-logistical-challenges-of-staggered-dosing-across-cohorts/#comments</comments>
		<pubDate>Tue, 21 Dec 2010 15:50:16 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Graham Wood, PhD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=259</guid>
		<description><![CDATA[Execution of an accelerated proof-of-concept study presents logistical challenges including:
•    Dosing as many as three parts of the study simultaneously,
•    Recruiting patients for the proof-of-concept cohort of the study, while the first cohort is ongoing,
•    Coordinating clinical, bioanalysis, data management, and pharmacokinetic analysis so informed decisions can be made by the safety committee.
An experienced study [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/12/can-you-explain-the-logistical-challenges-of-staggered-dosing-across-cohorts/feed/</wfw:commentRss>
		</item>
		<item>
		<title>How challenging is it to receive IRB approval for accelerated proof-of-concept study designs?</title>
		<link>http://randd.canon-experts.com/2010/12/1how-challenging-is-it-to-receive-irb-approval-for-accelerated-proof-of-concept-study-designs/</link>
		<comments>http://randd.canon-experts.com/2010/12/1how-challenging-is-it-to-receive-irb-approval-for-accelerated-proof-of-concept-study-designs/#comments</comments>
		<pubDate>Tue, 21 Dec 2010 15:48:46 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Graham Wood, PhD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=256</guid>
		<description><![CDATA[
Based on Cetero’s experience conducting accelerated proof-of-concept studies, the IRB approval process has been similar to standard first-in-human study approvals. As in first-in-human and proof-of-concept study designs, IRBs have established safety parameters to consider in accelerated proof-of-concept studies. In our experience, the main challenge with IRB approval involves demonstrating that adequate safety reviews are in [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/12/1how-challenging-is-it-to-receive-irb-approval-for-accelerated-proof-of-concept-study-designs/feed/</wfw:commentRss>
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