We are analyzing https://link.springer.com/chapter/10.1007/978-3-319-16241-6_8.

Title:
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...
Website Age:
28 years and 1 months (reg. 1997-05-29).

Matching Content Categories {📚}

Education
Science
Non-Profit & Charity

Content Management System {📝}

What CMS is link.springer.com built with?

Custom-built

No common CMS systems were detected on Link.springer.com, and no known web development framework was identified.

Traffic Estimate {📈}

What is the average monthly size of link.springer.com audience?

🌠 Phenomenal Traffic: 5M - 10M visitors per month

Based on our best estimate, this website will receive around 7,642,828 visitors per month in the current month.

check SE Ranking
check Ahrefs
check Similarweb
check Ubersuggest
check Semrush

How Does Link.springer.com Make Money? {💸}

We're unsure if the website is profiting.

While many websites aim to make money, others are created to share knowledge or showcase creativity. People build websites for various reasons. This could be one of them. Link.springer.com could have a money-making trick up its sleeve, but it's undetectable for now.

Keywords {🔍}

pubmed, google, scholar, article, cas, drug, april, accessed, liposomal, administration, cancer, release, plasma, human, drugs, pharmacokinetics, chapter, fda, food, products, nbcd, central, research, pharmacokinetic, guidance, res, doxorubicin, zamboni, methods, generic, pharm, medicinal, draft, european, stern, evaluation, separation, pegylated, content, complex, determination, ema, agency, tumor, nanoparticle, sci, chmp, nonbiological, bioequivalence, protein,

Topics {✒️}

=opportunity&mode=form&id=592788989854da145c8e7b6d103c898d&tab=core&tabmode=list org/sites/default/files/usp_pdf/en/uspnf/2011-02-25711dissolution gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm154838 eu/docs/en_gb/document_library/application_withdrawal_assessment_report/human/002049/wc500112957 gov/downloads/drugs/guidancecompliance-regulatoryinformation/guidances/ucm297630 eu/docs/en_gb/document_library/scientific_guideline/2009/09/wc500003011 eu/docs/en_gb/document_library/scientific_guideline/2011/07/wc500109479 eu/docs/en_gb/document_library/scientific_guideline/2011/04/wc500105048 eu/docs/en_gb/document_library/scientific_guideline/2013/02/wc500138390 eu/docs/en_gb/document_library/scientific_guideline/2013/09/wc500149496 gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm320015 gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm333051 gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm384094 gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm384173 gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm406256 gov/downloads/drugs/guidances/ucm070246 gov/downloads/drugs/guidances/ucm070244 gov/newsevents/newsroom/pressannouncements/ucm337872 cationic poly-l-lysine dendrimers liquid chromatography-mass spectroscopy gov/regulatoryinformation/legislation/ucm148717 month download article/chapter fluorescent-labeled albumin molecules cremophor el-mediated alteration line spe-spe-hplc gov/downloads/drugs/ liposomal short-chain ceramide process-induced drug release tumor-selective drug targeting nanoparticle-based therapeutics biological complex drugs macromolecular drugs based measure encapsulated/unencapsulated forms ultra-violet vd polyethylene glycol-coated privacy choices/manage cookies chlorine mpeg-pla european economic area gel-filtration chromatography solid phase extraction peg chain length active pharmaceutical ingredient iron sucrose bioequivalence aragon-ching jb preclinical tumor models device instant download innovator medicinal product refractory solid tumors protein precipitation techniques

Questions {❓}

Gov/index?

Schema {🗺️}

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
      isAccessibleForFree:
      hasPart:
         isAccessibleForFree:
         cssSelector:.main-content
         type:WebPageElement
      context:https://schema.org
Book:
      name:Non-Biological Complex Drugs
      isbn:
         978-3-319-16241-6
         978-3-319-16240-9
Organization:
      name:Springer International Publishing
      logo:
         url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
         type:ImageObject
      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
      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
ImageObject:
      url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
Person:
      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
      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
WebPageElement:
      isAccessibleForFree:
      cssSelector:.main-content

External Links {🔗}(231)

Analytics and Tracking {📊}

Google Tag Manager

Libraries {📚}

Clipboard.js
Particles.js

CDN Services {📦}

Pbgrd

4.62s.

LINK . SPRINGER . COM {}