ChloroquineV1, Main, Exploration, bibRecord, 001A21

Biowaiver monographs for immediate release solid oral dosage forms: Pyrazinamide

Identifieur interne : 001A21 ( Main/Exploration ); précédent : 001A20; suivant : 001A22

Biowaiver monographs for immediate release solid oral dosage forms: Pyrazinamide

Auteurs : C. Becker [Allemagne] ; J. B. Dressman [Allemagne] ; G. L. Amidon [États-Unis] ; H. E. Junginger [Thaïlande] ; S. Kopp [Suisse] ; K. K. Midha [Canada] ; V. P. Shah [Pays-Bas] ; S. Stavchansky [États-Unis] ; D. M. Barends [Pays-Bas]

Source :

Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 2008-09.

RBID : ISTEX:A5E02C0750BA378860A9592AB06E1D3FCCAC4458

English descriptors

Teeft :
- Amidon, Antituberculosis drugs, Barends, Becker, Bioavailability, Bioequivalence, Bioinequivalence, Biopharmaceutics system, Biowaiver, Biowaiver monograph, Biowaiver monographs, Clin, Clin pharmacol, Cmax, Dosage, Dosage forms, Dressman, Drug products, Electronic version, Essential medicines, Essential medicines list, Excipient, Excipients, Excretion, Fasted state, Goethe university, Healthy subjects, Hepatic, Hong kong, Immediate release, Isoniazid, Junginger, Latent tuberculosis infection, Literature data, Liver function, Midha, Monograph, Oral dosage forms, Oral dose, Peak serum concentrations, Permeability, Pharm, Pharmaceutical, Pharmaceutical press, Pharmaceutical sciences, Pharmaceutical technology, Pharmacokinetics, Polymorphic forms, Pyrazinamide, Pyrazinamide drug products, Pyrazinamide formulations, Pyrazinoic acid, Rifampicin, September, Shah, Solubility, Test product, World health organization.

Abstract

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing pyrazinamide as the only active pharmaceutical ingredient (API) are reviewed. Pyrazinamide is BCS Class III, with linear absorption over a wide dosing range. The risk of bioinequivalence is estimated to be low. Depending on the definition used, pyrazinamide can be classified as a narrow therapeutic index (NTI) drug, which is usually a caveat to biowaiving but may be deemed acceptable if the Summary of Product Characteristics (SmPCs) of the test product stipulates the need for regular monitoring of liver function. It is concluded that a biowaiver can be recommended for IR solid oral dosage only when the test product (a) contains only excipients present in pyrazinamide IR solid oral drug products approved in ICH or associated countries, (b) these excipients are present in amounts normally used in IR solid oral dosage forms, (c) the test product is very rapidly dissolving, (d) the SmPC of the test product indicates the need for monitoring of the patient's liver function. © 2008 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:3709–3720, 2008

Url:

DOI: 10.1002/jps.21250

Affiliations:

Le document en format XML

<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Biowaiver monographs for immediate release solid oral dosage forms: Pyrazinamide</title>
<author><name sortKey="Becker, C" sort="Becker, C" uniqKey="Becker C" first="C." last="Becker">C. Becker</name>
</author>
<author><name sortKey="Dressman, J B" sort="Dressman, J B" uniqKey="Dressman J" first="J. B." last="Dressman">J. B. Dressman</name>
</author>
<author><name sortKey="Amidon, G L" sort="Amidon, G L" uniqKey="Amidon G" first="G. L." last="Amidon">G. L. Amidon</name>
</author>
<author><name sortKey="Junginger, H E" sort="Junginger, H E" uniqKey="Junginger H" first="H. E." last="Junginger">H. E. Junginger</name>
</author>
<author><name sortKey="Kopp, S" sort="Kopp, S" uniqKey="Kopp S" first="S." last="Kopp">S. Kopp</name>
</author>
<author><name sortKey="Midha, K K" sort="Midha, K K" uniqKey="Midha K" first="K. K." last="Midha">K. K. Midha</name>
</author>
<author><name sortKey="Shah, V P" sort="Shah, V P" uniqKey="Shah V" first="V. P." last="Shah">V. P. Shah</name>
</author>
<author><name sortKey="Stavchansky, S" sort="Stavchansky, S" uniqKey="Stavchansky S" first="S." last="Stavchansky">S. Stavchansky</name>
</author>
<author><name sortKey="Barends, D M" sort="Barends, D M" uniqKey="Barends D" first="D. M." last="Barends">D. M. Barends</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:A5E02C0750BA378860A9592AB06E1D3FCCAC4458</idno>
<date when="2008" year="2008">2008</date>
<idno type="doi">10.1002/jps.21250</idno>
<idno type="url">https://api.istex.fr/ark:/67375/WNG-J97VZTWG-H/fulltext.pdf</idno>
<idno type="wicri:Area/Istex/Corpus">001A41</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001A41</idno>
<idno type="wicri:Area/Istex/Curation">001A41</idno>
<idno type="wicri:Area/Istex/Checkpoint">000927</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000927</idno>
<idno type="wicri:doubleKey">0022-3549:2008:Becker C:biowaiver:monographs:for</idno>
<idno type="wicri:Area/Main/Merge">001A30</idno>
<idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:027D7617A145FDFCF11D7895C0C48FBB26607F49</idno>
<idno type="url">https://api.istex.fr/ark:/67375/WNG-83X8NV7M-T/fulltext.pdf</idno>
<idno type="wicri:Area/Istex/Corpus">001A72</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001A72</idno>
<idno type="wicri:Area/Istex/Curation">001A72</idno>
<idno type="wicri:Area/Istex/Checkpoint">000926</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000926</idno>
<idno type="wicri:doubleKey">0022-3549:2008:Becker C:biowaiver:monographs:for</idno>
<idno type="wicri:Area/Main/Merge">001A29</idno>
<idno type="wicri:Area/Main/Curation">001A21</idno>
<idno type="wicri:Area/Main/Exploration">001A21</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title level="a" type="main">Biowaiver monographs for immediate release solid oral dosage forms: Pyrazinamide</title>
<author><name sortKey="Becker, C" sort="Becker, C" uniqKey="Becker C" first="C." last="Becker">C. Becker</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt</wicri:regionArea>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dressman, J B" sort="Dressman, J B" uniqKey="Dressman J" first="J. B." last="Dressman">J. B. Dressman</name>
<affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt</wicri:regionArea>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Amidon, G L" sort="Amidon, G L" uniqKey="Amidon G" first="G. L." last="Amidon">G. L. Amidon</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Michigan</region>
</placeName>
<wicri:cityArea>College of Pharmacy, University of Michigan, Ann Arbor</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Junginger, H E" sort="Junginger, H E" uniqKey="Junginger H" first="H. E." last="Junginger">H. E. Junginger</name>
<affiliation wicri:level="1"><country xml:lang="fr">Thaïlande</country>
<wicri:regionArea>Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok</wicri:regionArea>
<wicri:noRegion>Phitsanulok</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kopp, S" sort="Kopp, S" uniqKey="Kopp S" first="S." last="Kopp">S. Kopp</name>
<affiliation wicri:level="1"><country xml:lang="fr">Suisse</country>
<wicri:regionArea>WHO—World Health Organization, Geneva</wicri:regionArea>
<wicri:noRegion>Geneva</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Midha, K K" sort="Midha, K K" uniqKey="Midha K" first="K. K." last="Midha">K. K. Midha</name>
<affiliation wicri:level="1"><country xml:lang="fr">Canada</country>
<wicri:regionArea>University of Saskatchewan, Saskatoon, Saskatchewan</wicri:regionArea>
<wicri:noRegion>Saskatchewan</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Shah, V P" sort="Shah, V P" uniqKey="Shah V" first="V. P." last="Shah">V. P. Shah</name>
<affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>International Pharmaceutical Federation FIP, The Hague</wicri:regionArea>
<wicri:noRegion>The Hague</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Stavchansky, S" sort="Stavchansky, S" uniqKey="Stavchansky S" first="S." last="Stavchansky">S. Stavchansky</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<wicri:cityArea>Pharmaceutical Division, College of Pharmacy, University of Texas at Austin, Austin</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Barends, D M" sort="Barends, D M" uniqKey="Barends D" first="D. M." last="Barends">D. M. Barends</name>
<affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>RIVM—National Institute for Public Health and the Environment, Bilthoven</wicri:regionArea>
<wicri:noRegion>Bilthoven</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><country wicri:rule="url">Pays-Bas</country>
</affiliation>
<affiliation></affiliation>
</author>
</analytic>
<monogr></monogr>
<series><title level="j" type="main">Journal of Pharmaceutical Sciences</title>
<title level="j" type="alt">JOURNAL OF PHARMACEUTICAL SCIENCES</title>
<idno type="ISSN">0022-3549</idno>
<idno type="eISSN">1520-6017</idno>
<imprint><biblScope unit="vol">97</biblScope>
<biblScope unit="issue">9</biblScope>
<biblScope unit="page" from="3709">3709</biblScope>
<biblScope unit="page" to="3720">3720</biblScope>
<biblScope unit="page-count">12</biblScope>
<publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher>
<pubPlace>Hoboken</pubPlace>
<date type="published" when="2008-09">2008-09</date>
</imprint>
<idno type="ISSN">0022-3549</idno>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><idno type="ISSN">0022-3549</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Amidon</term>
<term>Antituberculosis drugs</term>
<term>Barends</term>
<term>Becker</term>
<term>Bioavailability</term>
<term>Bioequivalence</term>
<term>Bioinequivalence</term>
<term>Biopharmaceutics system</term>
<term>Biowaiver</term>
<term>Biowaiver monograph</term>
<term>Biowaiver monographs</term>
<term>Clin</term>
<term>Clin pharmacol</term>
<term>Cmax</term>
<term>Dosage</term>
<term>Dosage forms</term>
<term>Dressman</term>
<term>Drug products</term>
<term>Electronic version</term>
<term>Essential medicines</term>
<term>Essential medicines list</term>
<term>Excipient</term>
<term>Excipients</term>
<term>Excretion</term>
<term>Fasted state</term>
<term>Goethe university</term>
<term>Healthy subjects</term>
<term>Hepatic</term>
<term>Hong kong</term>
<term>Immediate release</term>
<term>Isoniazid</term>
<term>Junginger</term>
<term>Latent tuberculosis infection</term>
<term>Literature data</term>
<term>Liver function</term>
<term>Midha</term>
<term>Monograph</term>
<term>Oral dosage forms</term>
<term>Oral dose</term>
<term>Peak serum concentrations</term>
<term>Permeability</term>
<term>Pharm</term>
<term>Pharmaceutical</term>
<term>Pharmaceutical press</term>
<term>Pharmaceutical sciences</term>
<term>Pharmaceutical technology</term>
<term>Pharmacokinetics</term>
<term>Polymorphic forms</term>
<term>Pyrazinamide</term>
<term>Pyrazinamide drug products</term>
<term>Pyrazinamide formulations</term>
<term>Pyrazinoic acid</term>
<term>Rifampicin</term>
<term>September</term>
<term>Shah</term>
<term>Solubility</term>
<term>Test product</term>
<term>World health organization</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing pyrazinamide as the only active pharmaceutical ingredient (API) are reviewed. Pyrazinamide is BCS Class III, with linear absorption over a wide dosing range. The risk of bioinequivalence is estimated to be low. Depending on the definition used, pyrazinamide can be classified as a narrow therapeutic index (NTI) drug, which is usually a caveat to biowaiving but may be deemed acceptable if the Summary of Product Characteristics (SmPCs) of the test product stipulates the need for regular monitoring of liver function. It is concluded that a biowaiver can be recommended for IR solid oral dosage only when the test product (a) contains only excipients present in pyrazinamide IR solid oral drug products approved in ICH or associated countries, (b) these excipients are present in amounts normally used in IR solid oral dosage forms, (c) the test product is very rapidly dissolving, (d) the SmPC of the test product indicates the need for monitoring of the patient's liver function. © 2008 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:3709–3720, 2008</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Canada</li>
<li>Pays-Bas</li>
<li>Suisse</li>
<li>Thaïlande</li>
<li>États-Unis</li>
</country>
<region><li>District de Darmstadt</li>
<li>Hesse (Land)</li>
<li>Michigan</li>
<li>Texas</li>
</region>
<settlement><li>Francfort-sur-le-Main</li>
</settlement>
</list>
<tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Becker, C" sort="Becker, C" uniqKey="Becker C" first="C." last="Becker">C. Becker</name>
</region>
<name sortKey="Dressman, J B" sort="Dressman, J B" uniqKey="Dressman J" first="J. B." last="Dressman">J. B. Dressman</name>
</country>
<country name="États-Unis"><region name="Michigan"><name sortKey="Amidon, G L" sort="Amidon, G L" uniqKey="Amidon G" first="G. L." last="Amidon">G. L. Amidon</name>
</region>
<name sortKey="Stavchansky, S" sort="Stavchansky, S" uniqKey="Stavchansky S" first="S." last="Stavchansky">S. Stavchansky</name>
</country>
<country name="Thaïlande"><noRegion><name sortKey="Junginger, H E" sort="Junginger, H E" uniqKey="Junginger H" first="H. E." last="Junginger">H. E. Junginger</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Kopp, S" sort="Kopp, S" uniqKey="Kopp S" first="S." last="Kopp">S. Kopp</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Midha, K K" sort="Midha, K K" uniqKey="Midha K" first="K. K." last="Midha">K. K. Midha</name>
</noRegion>
</country>
<country name="Pays-Bas"><noRegion><name sortKey="Shah, V P" sort="Shah, V P" uniqKey="Shah V" first="V. P." last="Shah">V. P. Shah</name>
</noRegion>
<name sortKey="Barends, D M" sort="Barends, D M" uniqKey="Barends D" first="D. M." last="Barends">D. M. Barends</name>
<name sortKey="Barends, D M" sort="Barends, D M" uniqKey="Barends D" first="D. M." last="Barends">D. M. Barends</name>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/ChloroquineV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001A21 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001A21 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    ChloroquineV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     ISTEX:A5E02C0750BA378860A9592AB06E1D3FCCAC4458
   |texte=   Biowaiver monographs for immediate release solid oral dosage forms: Pyrazinamide
}}

This area was generated with Dilib version V0.6.33.
Data generation: Wed Mar 25 22:43:59 2020. Site generation: Sun Jan 31 12:44:45 2021

Serveur d'exploration Chloroquine

Biowaiver monographs for immediate release solid oral dosage forms: Pyrazinamide

Biowaiver monographs for immediate release solid oral dosage forms: Pyrazinamide

Source :

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

	Serveur d'exploration Chloroquine
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.