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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>Thu, 11 Feb 2010 21:14:13 +0000</pubDate>
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		<title>What advantages do microemulsion formulations offer specifically for topical and transdermal drug delivery?</title>
		<link>http://randd.canon-experts.com/2010/02/what-advantages-do-microemulsion-formulations-offer-specifically-for-topical-and-transdermal-drug-delivery/</link>
		<comments>http://randd.canon-experts.com/2010/02/what-advantages-do-microemulsion-formulations-offer-specifically-for-topical-and-transdermal-drug-delivery/#comments</comments>
		<pubDate>Thu, 11 Feb 2010 21:14:13 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[David M. Oakley, R.Ph., Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=205</guid>
		<description><![CDATA[The term &#8220;microemulsion&#8221; often used to describe a variety of micellar structures from simple droplets to complex cubic compositions. In this discussion, the classic definition is assumed:  a thermodynamically stable colloidal dispersion of water and oil stablized by a surfactant, and often, a co-surfactant.  In comparison with coarse emulsions, microemulsions form spontaneously, are [...]]]></description>
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		<title>What’s your take on the emergence of chronotherapeutic drug delivery systems, which control drug release according to circadian rhythms and the timing of symptoms? Does this technology offer potential benefit in treating chronic diseases such as ulcers, asthma, and cardiovascular disease, which display time-dependent symptoms?</title>
		<link>http://randd.canon-experts.com/2010/02/what%e2%80%99s-your-take-on-the-emergence-of-chronotherapeutic-drug-delivery-systems-which-control-drug-release-according-to-circadian-rhythms-and-the-timing-of-symptoms-does-this-technology-offer-p/</link>
		<comments>http://randd.canon-experts.com/2010/02/what%e2%80%99s-your-take-on-the-emergence-of-chronotherapeutic-drug-delivery-systems-which-control-drug-release-according-to-circadian-rhythms-and-the-timing-of-symptoms-does-this-technology-offer-p/#comments</comments>
		<pubDate>Thu, 11 Feb 2010 21:10:43 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[David M. Oakley, R.Ph., Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=202</guid>
		<description><![CDATA[As the questioner points out, there are benefits to dosing drugs with consideration of the normal and cyclical rhythms of human physiology.  Examples where disease conditions show cyclical patterns that correlate with circadian rhythms include:
Epilepsy: Seizures  may  occur only at particular times of the day or night
Allergies: Symptoms of sneezing and stuffy [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/02/what%e2%80%99s-your-take-on-the-emergence-of-chronotherapeutic-drug-delivery-systems-which-control-drug-release-according-to-circadian-rhythms-and-the-timing-of-symptoms-does-this-technology-offer-p/feed/</wfw:commentRss>
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		<title>Are there any ways to ameliorate the cardiac risks of a drug in development, if  such risks are detected early enough? Is it possible to &#8220;rescue&#8221; a drug that exhibits those risks in the early clinical stages? Or should the developer just move on?</title>
		<link>http://randd.canon-experts.com/2010/01/are-there-any-ways-to-ameliorate-the-cardiac-risks-of-a-drug-in-development-if-such-risks-are-detected-early-enough-is-it-possible-to-rescue-a-drug-that-exhibits-those-risks-in-the-early-clinic/</link>
		<comments>http://randd.canon-experts.com/2010/01/are-there-any-ways-to-ameliorate-the-cardiac-risks-of-a-drug-in-development-if-such-risks-are-detected-early-enough-is-it-possible-to-rescue-a-drug-that-exhibits-those-risks-in-the-early-clinic/#comments</comments>
		<pubDate>Wed, 27 Jan 2010 17:01:10 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Boaz Mendzelevski, MD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=190</guid>
		<description><![CDATA[Affirmative. There are several examples of drugs including antipsychotics and antiarrhythmic that had to be withdrawn from the market due to cardiotoxicity, in order to be reassessed and possibly redesigned. Some of these effects and adverse drug reactions (ADR), including unnecessary loss of lives, could have been prevented if dose-limiting toxicities had been appropriately assessed [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/01/are-there-any-ways-to-ameliorate-the-cardiac-risks-of-a-drug-in-development-if-such-risks-are-detected-early-enough-is-it-possible-to-rescue-a-drug-that-exhibits-those-risks-in-the-early-clinic/feed/</wfw:commentRss>
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		<title>What are the prospects for the expanded use of biomarkers in clinical trials to indicate cardiac risks? Are there any accepted biomarkers for cardiac risk at present? What is FDA&#8217;s stance on the use of these biomarkers as part of the submission for a drug?</title>
		<link>http://randd.canon-experts.com/2010/01/what-are-the-prospects-for-the-expanded-use-of-biomarkers-in-clinical-trials-to-indicate-cardiac-risks-are-there-any-accepted-biomarkers-for-cardiac-risk-at-present-what-is-fdas-stance-on-the-use/</link>
		<comments>http://randd.canon-experts.com/2010/01/what-are-the-prospects-for-the-expanded-use-of-biomarkers-in-clinical-trials-to-indicate-cardiac-risks-are-there-any-accepted-biomarkers-for-cardiac-risk-at-present-what-is-fdas-stance-on-the-use/#comments</comments>
		<pubDate>Wed, 27 Jan 2010 16:59:16 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Boaz Mendzelevski, MD]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=187</guid>
		<description><![CDATA[The primary, regulatory mandated, cardiac risk biomarkers (BM) used in pharmaceutical drug development are the electrophysiology assays defined in the ICH-S7B (non-clinical) and ICH-E14 (clinical) guidance. The non-clinical biomarkers/assays include the in vitro ion channel (hERG, K+ current) electrophysiology tests, tissue repolarization assays (Action Potential Duration; APD) using cardiac Purkinje fibers, and in vivo animal [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/01/what-are-the-prospects-for-the-expanded-use-of-biomarkers-in-clinical-trials-to-indicate-cardiac-risks-are-there-any-accepted-biomarkers-for-cardiac-risk-at-present-what-is-fdas-stance-on-the-use/feed/</wfw:commentRss>
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		<title>Do you see a discernable increase in demand for formulation development services, particularly in active preclinical formulations where it is often more difficult due to higher dosage levels?</title>
		<link>http://randd.canon-experts.com/2010/01/do-you-see-a-discernable-increase-in-demand-for-formulation-development-services-particularly-in-active-preclinical-formulations-where-it-is-often-more-difficult-due-to-higher-dosage-levels/</link>
		<comments>http://randd.canon-experts.com/2010/01/do-you-see-a-discernable-increase-in-demand-for-formulation-development-services-particularly-in-active-preclinical-formulations-where-it-is-often-more-difficult-due-to-higher-dosage-levels/#comments</comments>
		<pubDate>Tue, 19 Jan 2010 15:04:45 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[David M. Oakley, R.Ph., Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=178</guid>
		<description><![CDATA[Yes. Inquiries to our organization which involve preclinical programs where dosing levels have reached and, perhaps, exceeded limits for reasonable administration have increased. A reasonable explanation may be the increased percentage of new drugs with challenging biopharmaceutical properties. In a recent scientific forum, it was estimated that only 10% of new drugs meet the criteria [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/01/do-you-see-a-discernable-increase-in-demand-for-formulation-development-services-particularly-in-active-preclinical-formulations-where-it-is-often-more-difficult-due-to-higher-dosage-levels/feed/</wfw:commentRss>
		</item>
		<item>
		<title>How much promise do new technologies exploring oral insulin analogues – many just entering human testing – have in diabetes drug delivery? Can the traditional hurdles in oral administration be overcome?</title>
		<link>http://randd.canon-experts.com/2010/01/how-much-promise-do-new-technologies-exploring-oral-insulin-analogues-%e2%80%93-many-just-entering-human-testing-%e2%80%93-have-in-diabetes-drug-delivery-can-the-traditional-hurdles-in-oral-administr/</link>
		<comments>http://randd.canon-experts.com/2010/01/how-much-promise-do-new-technologies-exploring-oral-insulin-analogues-%e2%80%93-many-just-entering-human-testing-%e2%80%93-have-in-diabetes-drug-delivery-can-the-traditional-hurdles-in-oral-administr/#comments</comments>
		<pubDate>Tue, 19 Jan 2010 14:57:49 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[David M. Oakley, R.Ph., Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=180</guid>
		<description><![CDATA[We can look at the progress made in the oral delivery of insulin and predict similar successes for oral delivery of insulin analogues. Numerous technologies have been applied to oral insulin delivery to overcome the two primary obstacles: degradation and low membrane permeability. Examples of these technologies include enteric coatings, micro- and nano- particulates, mucoadhesives, [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/01/how-much-promise-do-new-technologies-exploring-oral-insulin-analogues-%e2%80%93-many-just-entering-human-testing-%e2%80%93-have-in-diabetes-drug-delivery-can-the-traditional-hurdles-in-oral-administr/feed/</wfw:commentRss>
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		<item>
		<title>What are the one or two, in your opinion, most promising novel imaging techniques emerging in Phase I and II studies, and which therapeutic areas do they have the greatest potential?</title>
		<link>http://randd.canon-experts.com/2010/01/most-promising-novel-imaging-techniques/</link>
		<comments>http://randd.canon-experts.com/2010/01/most-promising-novel-imaging-techniques/#comments</comments>
		<pubDate>Thu, 07 Jan 2010 14:47:17 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Richard Walovitch, Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=172</guid>
		<description><![CDATA[In Phase I and Phase II studies, dynamic-contrast enhanced magnetic resonance imaging (DCE-MRI) has shown promise in studying the pathophysiology of tumors. We currently measure tumor mass shrinkage to help determine potential efficacy, but DCE-MRI actually allows us to see changes in tumor vascularity by helping to measure blood flow in tissues and provide insight [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/01/most-promising-novel-imaging-techniques/feed/</wfw:commentRss>
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		<item>
		<title>What are the chief concerns regulators have regarding the use of data from independent imaging assessment committees in helping make endpoint decisions in oncology trials?</title>
		<link>http://randd.canon-experts.com/2010/01/independent-imaging-assessment/</link>
		<comments>http://randd.canon-experts.com/2010/01/independent-imaging-assessment/#comments</comments>
		<pubDate>Thu, 07 Jan 2010 14:45:36 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Richard Walovitch, Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=168</guid>
		<description><![CDATA[Regulators are primarily concerned with ensuring that all data is obtained independent from sponsor or imaging CRO bias and with minimal variability. Particularly important is the complete blinding of all clinical data provided to the endpoint assessment committee (EAC). The sponsor must be able to prove that all procedures adhere to pre-defined, study-specific guidelines that [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2010/01/independent-imaging-assessment/feed/</wfw:commentRss>
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		<title>Are the benefits of integrating IVR systems with other study management tools truly being realized, or do companies have a lot more kinks to work out in that area?</title>
		<link>http://randd.canon-experts.com/2009/10/are-the-benefits-of-integrating-ivr-systems-with-other-study-management-tools-truly-being-realized-or-do-companies-have-a-lot-more-kinks-to-work-out-in-that-area/</link>
		<comments>http://randd.canon-experts.com/2009/10/are-the-benefits-of-integrating-ivr-systems-with-other-study-management-tools-truly-being-realized-or-do-companies-have-a-lot-more-kinks-to-work-out-in-that-area/#comments</comments>
		<pubDate>Wed, 14 Oct 2009 19:41:06 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Dr. Bill Byrom, Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=163</guid>
		<description><![CDATA[Whilst such integrated services are relatively new to the industry, the acceptance of the concept and adoption of such integrated solutions is gaining momentum in the marketplace. Seamless data integration and interoperability between IVR systems and other study management tools is being developed as a direct response to sponsor and user requests to streamline the [...]]]></description>
		<wfw:commentRss>http://randd.canon-experts.com/2009/10/are-the-benefits-of-integrating-ivr-systems-with-other-study-management-tools-truly-being-realized-or-do-companies-have-a-lot-more-kinks-to-work-out-in-that-area/feed/</wfw:commentRss>
		</item>
		<item>
		<title>Has investigator acceptance of electronically managed drug accountability documentation caught up with their comfort level in other trial technologies, such as EDC?</title>
		<link>http://randd.canon-experts.com/2009/10/has-investigator-acceptance-of-electronically-managed-drug-accountability-documentation-caught-up-with-their-comfort-level-in-other-trial-technologies-such-as-edc/</link>
		<comments>http://randd.canon-experts.com/2009/10/has-investigator-acceptance-of-electronically-managed-drug-accountability-documentation-caught-up-with-their-comfort-level-in-other-trial-technologies-such-as-edc/#comments</comments>
		<pubDate>Wed, 14 Oct 2009 19:40:06 +0000</pubDate>
		<dc:creator>admin</dc:creator>
		
		<category><![CDATA[Dr. Bill Byrom, Ph.D.]]></category>

		<guid isPermaLink="false">http://randd.canon-experts.com/?p=160</guid>
		<description><![CDATA[For clients using EDA in an ongoing manner, sites are absolutely comfortable with the electronic process as it simplifies the workflow and centralizes all drug accountability information. Electronic drug accountability hasn’t yet had the widespread use that EDC now enjoys, so it is difficult to generalize any comparisons to EDC. However we are seeing good [...]]]></description>
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