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For this reason, we study in small proof of principle trials the fate, interactions and effectiveness of the injected DC.
The inflatable bag aerosol method, a concept introduced in 2009, has only completed proof of principle trials and has not yet entered pre-clinical trials.
They represent proof of principle trials, aimed at generating important data to guide the next stage (late phase clinical trials or guideline development).
The results of this study show that mRNA expression of IL-8 and MMP-1 quantified by Q-PCR may serve as biomarkers in small proof of principle trials designed to screen for potential efficacy in rheumatoid arthritis patients.
In the past and to some extent today, drug development in psychiatry deviated from step one in that serendipity usually based on clinical observation lead to small proof of principle trials, animal studies, and then to rational medical chemistry efforts [ 18], viz. the progression from imipramine to fluoxetine.
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Proof-of-principle trials have suggested that intramuscular injections of VLPs results in strong adaptive immune responses, both B- and T-cell mediated, that are capable of neutralizing subsequent natural infections.
The rationale behind the use of Ki-67 as a response biomarker in phase II proof-of-principle trials would be stronger if correlation could be established with development of cancer or with other biomarkers associated with a substantial increase in risk (atypical morphology and high mammographic density, for instance).
Evidence from proof-of-principle trials in Southeast Asia indicates that home-based counselling in pregnancy and shortly after childbirth, combined with community-based treatment or referral of sick babies, can result in higher coverage of recommended newborn care practices [ 7], leading to reductions in neonatal mortality of between 34 and 62% [ 7- 9].
The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle.
Now a proof-of-principle trial suggests a simple solution: GM pollen could contain an additional gene that would kill any weedy offspring.
Therefore, the GIPS-III trial may be regarded as a proof-of-principle trial focused on the cardioprotective effects of metformin.
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