Trends in microdosing and other exploratory human pharmacokinetic studies for early drug development.
Bioanalysis March 1, 2010
Trends in microdosing and other exploratory human pharmacokinetic studies for early drug development.
Microdosing: all studies
Page 30 of 56: studies 291 to 300 of 555, newest first. Back to the microdosing overview
Research
Welcome to 'microdosing'.
Bioanalysis March 1, 2010
Welcome to 'microdosing'.
Opinion: Microdosing: safer clinical trials and fewer animal tests.
Bioanalysis March 1, 2010
Opinion: Microdosing: safer clinical trials and fewer animal tests.
Microdosing in early lead discovery.
Bioanalysis March 2010 A P Jekunen, E K J Pauwels, K J A Kairemo
Microdosing provides a tool to enhance drug development by initiating human studies prior to Phase I studies. The purpose is to assist in the go versus no-go decision-making process and to eliminate early ineffective compounds from the drug pipeline. Selection of multiple potential leads can be performed at the clinical stage instead of in preclinical studies. The microdosing approach can be...
Human microdosing for the prediction of patient response
Bioanalysis March 1, 2010 Paul T. Henderson, C. Pan
Microdosing allows study of the behavior of drugs via the administration of doses so low they are unlikely to produce whole-body effects, but of sufficient concentration to allow the determination of absorption, distribution, metabolism and excretion (ADME). Microdosing was recently reviewed elsewhere [1,2]; although most effort to date has focused on pharmacokinetic (PK) predictions to...
Microdosing: Current and The Future
Bioanalysis March 1, 2010 Graham Lappin 36 citations
The concept of microdosing has been around for approximately 10 years. In this time there have been an increasing number of drugs reported in the literature where the pharmacokinetics at a microdose have been compared with those observed at a therapeutic dose. Currently, approximately 80% of the microdose pharmacokinetics available in the public domain have been shown to scale to those observed...
Microdosing for early biokinetic studies in humans.
Radiation protection dosimetry 2010 K Stenström, M Sydoff, S Mattsson
Microdosing is a new concept in drug development that--if implemented in the pharmaceutical industry--would mean that new drugs can be tested earlier in humans than done today. The human microdosing concept--or 'Phase 0'--may offer improved candidate selection, reduced failure rates in the drug development line and a reduction in the use of laboratory animals in early drug development, factors...
Is It Time to Advance the Chemoprevention of Environmental Carcinogenesis with Microdosing Trials?
Cancer Prevention Research December 1, 2009 Thomas W. Kensler, John D. Groopman
Abstract This perspective on Jubert et al. (beginning on page [1015] in this issue of the journal) discusses the use of microdosing with environmental carcinogens to accelerate the evaluation and optimization of chemopreventive interventions. The need for chemoprevention of environmental carcinogenesis is considered, as are the structure of microdosing, or phase 0, trials, technologies required...
Microdosing imaging pharmacokinetic (PK) study of the antisense oligonucleotide (ASO) to survivin (LY2181308) using positron emission tomography (PET): A novel paradigm in clinical drug development
Journal of Clinical Oncology May 20, 2009 A. Saleem, M. Ranson, S. Callies et al.
3578 Background: Survivin, an inhibitor of an apoptosis protein, widely overexpressed in cancer is associated with poor clinical outcome. We performed the first worldwide human microdosing imaging PK study of an ASO with LY2181308, a specific, second generation antisense inhibitor of Survivin using carbon-11 radiolabelled LY2181308 ([11C]LY2181308). Methods: LY2181308 was administered at the...
Design of a phase 0 microdosing trial for correlation of platinum-induced DNA damage to chemotherapy outcomes
Journal of Clinical Oncology May 20, 2009 C. Pan, T. Li, M. He et al.
2543 Background: DNA damage is the critical step in cancer cell response to platinum (Pt) chemotherapy. We hypothesize that low levels of Pt-induced DNA damage are predictive of chemoresistance. Accelerator mass spectrometry (AMS), an ultrasensitive method for measuring radiocarbon, can detect [14C]carboplatin bound to the DNA of cancer cells from cell culture, mice bearing tumor xenografts and...