Linked Life Data

21453049

Source:http://linkedlifedata.com/resource/pubmed/id/21453049

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
2011-6-8
pubmed:abstractText
In April 2010 a workshop on the "Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products" was sponsored by the Product Quality Research Institute (PQRI) in coordination with Respiratory Drug Delivery (RDD) 2010. The objective of the workshop was to evaluate the current state of knowledge and identify gaps in information relating to the potential use of pharmacokinetics (PK) as the key indicator of in vivo bioequivalence (BE) of locally acting orally inhaled products (OIPs). In addition, the strengths and limitations of the PK approach to detect differences in product performance compared with in vitro and pharmacodynamic (PD)/clinical/therapeutic equivalence (TE) studies were discussed. The workshop discussed the relationship between PK and lung deposition, in vitro assessment, and PD studies and examined potential PK study designs that could serve as pivotal BE studies. It has been recognized that the sensitivity to detect differences in product performance generally decreases as one moves from in vitro testing to PD measurements. The greatest challenge in the use of PD measurements with some OIPs (particularly inhaled corticosteroids) is the demonstration of a dose-response relationship (for local effects), without which the bioassay, and hence a PD study, may not have sufficient sensitivity to detect differences in product performance. European authorities allow demonstration of in vivo BE of OIPs based solely on pharmacokinetic studies. This workshop demonstrated broader interest among discipline experts and regulators to explore approaches for the use of PK data as the key determinant of in vivo equivalence of locally acting OIPs. If accepted, the suggested approach (PK alone or in conjunction with in vitro tests) could potentially be applied to demonstrate BE of certain orally inhaled drugs.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
T
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
1941-2703
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
24
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
119-35
pubmed:meshHeading
pubmed:year
2011
pubmed:articleTitle
Role of pharmacokinetics in establishing bioequivalence for orally inhaled drug products: workshop summary report.
pubmed:affiliation
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut 06877-0368, USA. dennis.oconnor@boehringer-ingelheim.com
pubmed:publicationType
Congresses