DOI . ORG {
}
We began analyzing https://link.springer.com/chapter/10.1007/978-3-319-16241-6_8, but it redirected us to https://link.springer.com/chapter/10.1007/978-3-319-16241-6_8. The analysis below is for the second page.
Title[redir]:
NBCD Pharmacokinetics and Bioanalytical Methods to Measure Drug Release | SpringerLink
Description:
A primary regulatory challenge for generics of non-biological complex drugs (NBCDs) (i.e., NBCD similars or nanosimilars) is evaluation of bioequivalence (i.e., pharmacokinetic equivalence). NBCD pharmacokinetics are highly dependent upon drug release kinetics and...
Title[redir]:
NBCD Pharmacokinetics and Bioanalytical Methods to Measure Drug Release | SpringerLink
Description:
A primary regulatory challenge for generics of non-biological complex drugs (NBCDs) (i.e., NBCD similars or nanosimilars) is evaluation of bioequivalence (i.e., pharmacokinetic equivalence). NBCD pharmacokinetics are highly dependent upon drug release kinetics and...
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ScholarlyArticle:
headline:NBCD Pharmacokinetics and Bioanalytical Methods to Measure Drug Release
pageEnd:287
pageStart:261
image:https://media.springernature.com/w153/springer-static/cover/book/978-3-319-16241-6.jpg
genre:
Biomedical and Life Sciences
Biomedical and Life Sciences (R0)
isPartOf:
name:Non-Biological Complex Drugs
isbn:
978-3-319-16241-6
978-3-319-16240-9
type:Book
publisher:
name:Springer International Publishing
logo:
url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
type:ImageObject
type:Organization
author:
name:Vishakha V. Ambardekar
affiliation:
name:Frederick National Laboratory for Cancer Research
address:
name:Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, USA
type:PostalAddress
type:Organization
type:Person
name:Stephan T. Stern
affiliation:
name:Frederick National Laboratory for Cancer Research
address:
name:Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, USA
type:PostalAddress
type:Organization
email:[email protected]
type:Person
keywords:Nanomedicine, Non-biological complex drugs, Pharmacokinetics, Bioanalytical methods, Drug release methods, Equilibrium dialysis, Liquid-liquid extraction, Modeling and simulation, Metabolite pharmacokinetics, Size exclusion chromatography, Solid phase extraction, Ultracentrifugation, Ultrafiltration
description:A primary regulatory challenge for generics of non-biological complex drugs (NBCDs) (i.e., NBCD similars or nanosimilars) is evaluation of bioequivalence (i.e., pharmacokinetic equivalence). NBCD pharmacokinetics are highly dependent upon drug release kinetics and dynamic tissue distribution, with the simultaneous existence of both NBCD encapsulated (e.g., bound) and unencapsulated (e.g. free) forms of the active pharmaceutical ingredient (API). For this reason, regulators have focused on the importance of evaluation of NBCD drug release, and the pharmacokinetics of both the encapsulated and unencapsulated forms of the API, which is challenging from a bioanalytical perspective. While many separation methods are currently available to evaluate drug release from NBCD formulations and measure encapsulated/unencapsulated forms of the API, including both direct and indirect methods, the most appropriate method for any particular NBCD type ultimately depends upon a combination of existing experience, scientific intuition, and trial and error. Presently, the available separation techniques have arisen from repurposing of small molecule preparatory and protein binding methods, none of which adequately address all concerns, such as the problems of process-induced drug release and accurate determination of unbound drug. This chapter will review the existing regulatory guidance for NBCD generic bioequivalence, as well as methods to evaluate NBCD drug release and pharmacokinetics.
datePublished:2015
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isbn:
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name:Frederick National Laboratory for Cancer Research
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address:
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type:PostalAddress
type:Organization
name:Stephan T. Stern
affiliation:
name:Frederick National Laboratory for Cancer Research
address:
name:Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, USA
type:PostalAddress
type:Organization
email:[email protected]
PostalAddress:
name:Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, USA
name:Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, USA
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