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Abstract
MICRODOSING OR PHASE 0
An early phase of a trial has a vital role in the unprecedented expansion of the clinical trial sector and the drug development process in the emerging era. Micro dosing as the name reflects its definition, in this phase, healthy volunteers are administered a drug at doses of 100 micrograms or 1/100th of a normal dose, whichever is lesser. At such low doses volunteers are not exposed to drug toxicity but still drug effect can be determined because the drug is bound to a radiolig and which makes it easier for the detection of even minute amount of dosage .By possible powerful detection techniques like accelerator mass spectroscopy and positron emission tomography samples are drawn and pharmacokinetics as well as pharmacodynamics can be studied .Thus it is helpful for both the patients and the pharmaceutical organisations as this stands as an attractive approach that requires only few preclinical studies , phase 1 trial and a reduced amount of candidate drug on human beings . Microdosing has a promising role in the study of drug- drug interaction besides pharmacokinetic aspects.
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References
- [1]. Dimasi JA, Hansen RW, Grabowski HG.(2003). The price of innovation. New estimates of drug development costs. Journal of health economics; 2(22): 151-85.
- [2]. Bikas medhi, Ajay prakash.(2010). Practical manual of experimental and clinical pharmacology. : Jaypee; 351.
- [3]. Berend oosterhuis. (2010). Trends in microdosing and other exploratory human pharmacokinetic studies for early drug development. Bioanalysis. : 377-379.
- [4]. Ranjan Kumar Patel. Latest development in clinical trials, First edition: Cbs publishers; 2015.
- [5]. Graham Lappin. (2010).Microdosing: Current and the future; Bio analysis. ; .
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- [7]. Aboagye EO, Price PM et al. (2001).In vivo pharmacokinetics and pharmacodynamics in drug development using PET. Drug discovery today. : ; . 293-302.
- [8]. G.Lappin, R.C.Garner. (2005). the use of accelerator mass spectroscopy to obtain early human ADME/PK Data, Expert opinion in Drug metabolism and toxicology ed.:23-31.
- [9]. Bikas medhi, Ajay prakash. (2010). Practical manual of experimental and clinical pharmacology. :351.
- [10]. G. Lappin, W. Kuhnz, R. Jochemsen, J. Kneer, A. Chaudhary, B. Oosterhuis et al. (2006). Use of microdosing to predict pharmacokinetics at the therapeutic dose, 80 ed.: 203-215.
- [11]. Bhavesh N.Chauhan, Chirag M Modi et al. Pharmacoeconomics of microdosing clinical trials in Drug Develeopment Process. 2012; 1(2278-0246).
References
[1]. Dimasi JA, Hansen RW, Grabowski HG.(2003). The price of innovation. New estimates of drug development costs. Journal of health economics; 2(22): 151-85.
[2]. Bikas medhi, Ajay prakash.(2010). Practical manual of experimental and clinical pharmacology. : Jaypee; 351.
[3]. Berend oosterhuis. (2010). Trends in microdosing and other exploratory human pharmacokinetic studies for early drug development. Bioanalysis. : 377-379.
[4]. Ranjan Kumar Patel. Latest development in clinical trials, First edition: Cbs publishers; 2015.
[5]. Graham Lappin. (2010).Microdosing: Current and the future; Bio analysis. ; .
[6]. Microdosing in translational medicine: pros and cons Advances reports. Cambridge health associates. :5-5.
[7]. Aboagye EO, Price PM et al. (2001).In vivo pharmacokinetics and pharmacodynamics in drug development using PET. Drug discovery today. : ; . 293-302.
[8]. G.Lappin, R.C.Garner. (2005). the use of accelerator mass spectroscopy to obtain early human ADME/PK Data, Expert opinion in Drug metabolism and toxicology ed.:23-31.
[9]. Bikas medhi, Ajay prakash. (2010). Practical manual of experimental and clinical pharmacology. :351.
[10]. G. Lappin, W. Kuhnz, R. Jochemsen, J. Kneer, A. Chaudhary, B. Oosterhuis et al. (2006). Use of microdosing to predict pharmacokinetics at the therapeutic dose, 80 ed.: 203-215.
[11]. Bhavesh N.Chauhan, Chirag M Modi et al. Pharmacoeconomics of microdosing clinical trials in Drug Develeopment Process. 2012; 1(2278-0246).