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Adaptive Seamless Design
Adaptive Seamless Design

... Standard trial designs allow little learning during the conduct of the trial “Established” Established” adaptations are used in groupgroup-sequential trials where stopping for superiority or futility can be done according to pre pre-defined rules at interim analyses Clearly separated development pha ...
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...  At amnesia and analgesia doses; proper pretreatment with a benzo will help eliminate the psychological effects if any….  Keeping doses less than 1 mg/kg with a benzo is the max benefit of both drugs  Watch the eyes ...
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... DCE-CT has been suggested for these purposes due to its lower cost in comparison to MRI. However, two challenges need to be overcome before DCE-CT can be used routinely in clinical drug trials. Firstly, protocols need to be devised that have sufficiently low radiation dose to make it ethically accep ...
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Biosafety Application, Human Gene Transfer Clinical Trials
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... Human Gene Transfer Clinical Trials I understand that for any experiment involving the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human research participants (Human Gene Transfer), no research participant may be enrolled, until the entire review and appr ...
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... Q.43 A 30 year old female developed antibiotic-induced colitis due to C. difficile; she was given Metronidazole to treat it but it proved ineffective. Now she can respond to oral: a) Amoxicillin. b) Erythromycin. c) Chloramphenicol. d) Doxycycline. e) Vancomycin. Q.44 Erythromycin is an older macrol ...
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...  Physical dependence - is a state of adaption that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction decreasing blood level of the drug or administration of an antagonist.  Tolerance - is a state of adaptation in which exposur ...
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... antibiotics the drug application is possible in combination with antibiotic therapy. In case of specific bacteriophages correcting therapy, Lactobacterinum-Biopharma should be administered after treatment with bacteriophage. Administration details. It is unacceptable to dissolve the drug in hot wate ...
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... efficacy of a new chemical entity is crucial. Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether the drug should be tested in people. ...
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