Editorial
Effective Use of Microdosing and Positron Emission Tomography (PET) Studies on New Drug Discovery and Development

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    Standardized uptake value (SUV) is a simple image-based measure, widely used in clinical practice, calculated as the ratio of tissue radioactivity concentration (i.e., in kBq/mL) at a given time divided by the administered dose at the time of injection (i.e., in MBq) per body weight (i.e., in kg). Clinically, PET has been primarily utilized for visualizing the metabolic demands of cancers within the body [60–62], however this common analytical technique has been exploited to aid in phase 0/microdosing studies to increase success in preclinical drug development [63–65]. Bacterial infections are often times deeply rooted infections that are difficult to precisely locate with simple blood sampling that merely indicates whether there is an infection.

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    Now it is playing an increasing role in both drug discovery and development by assessing their pharmacokinetics and pharmacodynamics. It is noteworthy that many PET tracers used for cancer detection are thought to be substrates of specific transporters [64,65]. To evaluate the functions of P-gp and BCRP in Caco-2 cells, Yamasaki T et al. carried out a small animal PET study using [11C]GF120918.

  • Approaches using molecular imaging technology - use of PET in clinical microdose studies

    2011, Advanced Drug Delivery Reviews
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    Because a minimum of safety and toxicology testing is required by regulative authorities before microdose studies can be conducted [2,3], drug candidates with a favorable PK profile can be selected at an early stage of drug development. In Japan, guidelines for microdosing in clinical trials were released in 2008 [4]. A precondition for extrapolating plasma or tissue concentrations of a drug after administration of a microdose to drug concentrations achieved with a therapeutic dose is that drug concentrations in plasma and tissue increase linearly, with increasing drug doses administered.

  • Ethical, legal, and social implications (ELSI) of microdose clinical trials

    2011, Advanced Drug Delivery Reviews
    Citation Excerpt :

    and “Is it true that the microdosing strategy improves the success rate of clinical drug development toward marketing authorization?” To respond to this question, there have been three big projects in the world to demonstrate the predictability of the pharmacokinetics in the therapeutic dose from that in the microdose: “Consortium for Resourcing and Evaluating AMS Microdosing (CREAM) trial” [1], “The European Union Microdose AMS Partnership Programme (EUMAPP) [2]”, both in Europe, and “Innovative strategies for drug development using microdosing clinical studies” (NEDO MicroDose-PJ) [3] in Japan. The author has been engaged in the third one, with the role of management for ethical conduct of clinical studies, and also of integrating ELSI studies on microdosing.

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