Linked Life Data

21067462

Source:http://linkedlifedata.com/resource/pubmed/id/21067462

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
12
pubmed:dateCreated
2010-11-16
pubmed:abstractText
The FDA and the International Conference on Harmonization (ICH) recently issued regulatory guidance on metabolites in safety testing (MIST). One of the key differences between these two types of guidance is the threshold for a major metabolite: > 10% of AUC of the parent drug at steady-state (the FDA) versus > 10% of drug-related exposure (ICH). The FDA agreed to adopt the ICH M3 threshold in 2010. Both guidance require metabolite profiling in humans during early clinical development which have presented significant challenges from two aspects: i) how to balance the recommendation of front-loading of metabolism studies with the need to invest resources appropriately according to the stage of drug development and ii) how to fully utilize alternative bioanalytical approaches to generate reliable data for enabling prompt and informed decisions, without always resorting to resource-intensive good laboratory practices bioanalysis. Areas covered in this review: This review summarizes current thinking in the pharmaceutical industry on these two aspects.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
1744-7607
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
6
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1539-49
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
Challenges and solutions to metabolites in safety testing: impact of the International Conference on Harmonization M3(R2) guidance.
pubmed:affiliation
Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USA. hongbin.yu@boehringer-ingelheim.com
pubmed:publicationType
Journal Article, Review