Abstract:
:There is an increasing recognition within the pharmaceutical industry of the importance of the ADME studies in drug registration. Consequently, there has been a drive in recent times to conduct the ADME studies as early as possible in the development programme. There are, however, regulatory barriers, particularly in the administration of radiotracers to human volunteers, which place limitations on the timing of the ADME studies. Accelerator mass spectrometry (AMS), a technology new to the pharmaceutical industry, is an ultrasensitive technique for measuring tracers such as (14)C. Using AMS, it is possible to lower the radioactive dose administered to humans to a point where many regulatory authorities consider it insignificant. With the removal of the regulatory hurdles, ADME data can be obtained much earlier in the development process. Tracers such as (14)C can be administered in minute amounts in the first in man studies (Phase I), or even in a preregulatory study known as microdosing (or human Phase 0). AMS also enables other studies such as absolute bioavailability to be conducted earlier if required.
journal_name
Expert Opin Drug Metab Toxicoljournal_title
Expert opinion on drug metabolism & toxicologyauthors
Lappin G,Garner RCdoi
10.1517/17425255.1.1.23subject
Has Abstractpub_date
2005-06-01 00:00:00pages
23-31issue
1eissn
1742-5255issn
1744-7607journal_volume
1pub_type
杂志文章,评审abstract:INTRODUCTION:Organic anion transporting polypeptide (OATP) uptake transporters are important for the disposition of many drugs and perturbed OATP activity can contribute to adverse drug reactions (ADRs). It is well documented that both genetic and environmental factors can alter OATP expression and activity. Genetic fa...
journal_title:Expert opinion on drug metabolism & toxicology
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abstract::Introduction: Overactive bladder (OAB) has a heterogeneous presentation that varies between individuals and by gender. Treatment with antimuscarinic medications is standard first line pharmacotherapy for most patients with OAB. However, gender specific differences in the pharmacokinetics and pharmacodynamics of antimu...
journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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更新日期:2015-01-01 00:00:00
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journal_title:Expert opinion on drug metabolism & toxicology
pub_type: 杂志文章,评审
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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更新日期:2015-07-01 00:00:00
abstract:INTRODUCTION:First- and second-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), such as gefitinib, erlotinib, icotinib, and afatinib are the standard-of-care for first-line therapy of non-small-cell lung cancer (NSCLC) harboring activating EGFR mutations. Unfortunately, after initial ...
journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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更新日期:2012-09-01 00:00:00
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journal_title:Expert opinion on drug metabolism & toxicology
pub_type: 杂志文章,评审
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更新日期:2012-03-01 00:00:00
abstract:INTRODUCTION:Adverse drug reactions with an immune pathogenesis are a problem in the clinic and an impediment to drug development. T lymphocytes are believed to play a role in the pathogenesis; however, the nature of the drug interaction with immune receptors remains an area of debate. AREAS COVERED:This article revie...
journal_title:Expert opinion on drug metabolism & toxicology
pub_type: 杂志文章,评审
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更新日期:2015-03-01 00:00:00
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journal_title:Expert opinion on drug metabolism & toxicology
pub_type: 杂志文章,评审
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journal_title:Expert opinion on drug metabolism & toxicology
pub_type: 杂志文章,评审
doi:10.1517/17425250902976862
更新日期:2009-07-01 00:00:00
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
pub_type: 杂志文章,评审
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
pub_type: 杂志文章,评审
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更新日期:2016-01-01 00:00:00
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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journal_title:Expert opinion on drug metabolism & toxicology
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更新日期:2016-12-01 00:00:00
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