<menuitem id="jdttp"></menuitem><ins id="jdttp"></ins><cite id="jdttp"><noframes id="jdttp"><cite id="jdttp"></cite><menuitem id="jdttp"><span id="jdttp"><menuitem id="jdttp"></menuitem></span></menuitem>
<ins id="jdttp"><noframes id="jdttp"><ins id="jdttp"></ins>
<cite id="jdttp"></cite>
<cite id="jdttp"><noframes id="jdttp"> <ins id="jdttp"><noframes id="jdttp"><cite id="jdttp"></cite>
<cite id="jdttp"><noframes id="jdttp">
<ins id="jdttp"></ins>
<ins id="jdttp"></ins>
<del id="jdttp"><noframes id="jdttp">
<del id="jdttp"></del><cite id="jdttp"><noframes id="jdttp"><cite id="jdttp"><span id="jdttp"></span></cite>
Home > Contract Research Services > Clinical Services

Based on molecular imaging technology, services scope:
• Clinical study protocol design and drafting;
• Selecting sites to be involved;
• Communication with Ethic committee;
• Sites' monitoring;
• Data management & Statistical analysis;
• Clinical study report design and drafting

Phase 0 trials are first-in-human studies that are conducted prior to traditional dose-finding phase I trials. Phase 0 trials are involved in only a few patients (usually 10-12) who are exposed to a limited number (fewer than 7 days) of low doses of an investigational drug, either microdoses (defined as less than 1/100th of the pharmacologically active dose as determined in an animal models) or sub-therapeutic but pharmacologically active doses.

Phase 0 trials provide a platform to access the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an agent in humans very early in the drug evaluation process. Data generated from such trials can inform the subsequent development of the agent, providing a rational basis for “go” and “not go” clinical decisions.

The objectives of phase 0 trials include:
1.Determining whether the mechanism of action defined in preclinical models can be demonstrated in human;
2.Evaluating PK-PD relationship;
3.Refining a qualified PD assay in human tissues;
4.Optimizing the sequence and schedule of drug combinations;
5.Selecting a lead agent from analogs based on human PK/PD data; and
6.Examining agent biodistribution, binding, and target effects in human, using highly sensitive imagining technologies.  

Not all novel agents need to undergo phase 0 testing prior to undergoing traditional phase I evaluation. The commitment to conduct a phase 0 trial should be based on strong preclinical data with clear decision points affecting the future development of the agent. (See below flow chart referred)

MITRO uses PET/SPECT and other molecular imaging technologies to provide phase 0 research services for new drugs. These technologies enable bio-distribution, targeting and mechanism studies of drugs in human bodies in an early research stage, helping drug R&D institutes to make correct decisions quickly and providing important basis for making R&D and investment decisions.


GOGO西西人体大尺寸大胆高清,国产丰满大波大屁股熟女,图片区乱小说区电影区,4399日本电影免费观看完整版
<menuitem id="jdttp"></menuitem><ins id="jdttp"></ins><cite id="jdttp"><noframes id="jdttp"><cite id="jdttp"></cite><menuitem id="jdttp"><span id="jdttp"><menuitem id="jdttp"></menuitem></span></menuitem>
<ins id="jdttp"><noframes id="jdttp"><ins id="jdttp"></ins>
<cite id="jdttp"></cite>
<cite id="jdttp"><noframes id="jdttp"> <ins id="jdttp"><noframes id="jdttp"><cite id="jdttp"></cite>
<cite id="jdttp"><noframes id="jdttp">
<ins id="jdttp"></ins>
<ins id="jdttp"></ins>
<del id="jdttp"><noframes id="jdttp">
<del id="jdttp"></del><cite id="jdttp"><noframes id="jdttp"><cite id="jdttp"><span id="jdttp"></span></cite>