Toxicological overview of impurities in pharmaceutical products
While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control...
Gespeichert in:
| Veröffentlicht in: | Advanced drug delivery reviews 2007-01, Vol.59 (1), p.38-42 |
|---|---|
| Hauptverfasser: | , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 42 |
|---|---|
| container_issue | 1 |
| container_start_page | 38 |
| container_title | Advanced drug delivery reviews |
| container_volume | 59 |
| creator | Jacobson-Kram, David McGovern, Timothy |
| description | While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This chapter discusses practical and theoretical methods for qualification of different classes of impurities. |
| doi_str_mv | 10.1016/j.addr.2006.10.007 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_33196499</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0169409X06002742</els_id><sourcerecordid>33196499</sourcerecordid><originalsourceid>FETCH-LOGICAL-c416t-f1bf73a4884c2650e7ea8d999214b555791866f8a0d1e2f5674fce0291da4fad3</originalsourceid><addsrcrecordid>eNqFkMtKAzEUhoMoWi8v4EJm5W5qkmZyAUFEvIHgRsFdSJMTTZlpajJT9e1NbcGdrg4cvv8_hw-hY4LHBBN-Nhsb59KYYszLYoyx2EIjIgWtJVVsG40KpGqG1cse2s95hjGhguNdtEcEkVIINUIXT_Ez2NjG12BNW8UlpGWAjyr6KnSLIYU-QK7CvFq8mdQZC0P_Ay5SdIPt8yHa8abNcLSZB-j55vrp6q5-eLy9v7p8qC0jvK89mXoxMUxKZilvMAgw0imlKGHTpmmEIpJzLw12BKhvuGDeAqaKOMO8cZMDdLruLYffB8i97kK20LZmDnHIejIhijOl_gUppg0ubxSQrkGbYs4JvF6k0Jn0pQnWK796pld-9crvalf8ltDJpn2YduB-IxuhBThfA1BkFJNJZxtgbsGFBLbXLoa_-r8BpUKMPQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>20250884</pqid></control><display><type>article</type><title>Toxicological overview of impurities in pharmaceutical products</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Jacobson-Kram, David ; McGovern, Timothy</creator><creatorcontrib>Jacobson-Kram, David ; McGovern, Timothy</creatorcontrib><description>While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This chapter discusses practical and theoretical methods for qualification of different classes of impurities.</description><identifier>ISSN: 0169-409X</identifier><identifier>EISSN: 1872-8294</identifier><identifier>DOI: 10.1016/j.addr.2006.10.007</identifier><identifier>PMID: 17188779</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Drug Contamination ; Europe ; European Medicines Agency (EMEA) ; Genotoxic impurities ; Guidelines as Topic ; Humans ; International Cooperation ; Mutagens - analysis ; Mutagens - toxicity ; Pharmaceutical impurities ; Pharmaceutical Preparations - analysis ; Risk Assessment ; Toxicology ; United States ; United States Food and Drug Administration</subject><ispartof>Advanced drug delivery reviews, 2007-01, Vol.59 (1), p.38-42</ispartof><rights>2006 Elsevier B.V.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c416t-f1bf73a4884c2650e7ea8d999214b555791866f8a0d1e2f5674fce0291da4fad3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.addr.2006.10.007$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,778,782,3539,27907,27908,45978</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17188779$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jacobson-Kram, David</creatorcontrib><creatorcontrib>McGovern, Timothy</creatorcontrib><title>Toxicological overview of impurities in pharmaceutical products</title><title>Advanced drug delivery reviews</title><addtitle>Adv Drug Deliv Rev</addtitle><description>While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This chapter discusses practical and theoretical methods for qualification of different classes of impurities.</description><subject>Drug Contamination</subject><subject>Europe</subject><subject>European Medicines Agency (EMEA)</subject><subject>Genotoxic impurities</subject><subject>Guidelines as Topic</subject><subject>Humans</subject><subject>International Cooperation</subject><subject>Mutagens - analysis</subject><subject>Mutagens - toxicity</subject><subject>Pharmaceutical impurities</subject><subject>Pharmaceutical Preparations - analysis</subject><subject>Risk Assessment</subject><subject>Toxicology</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>0169-409X</issn><issn>1872-8294</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMtKAzEUhoMoWi8v4EJm5W5qkmZyAUFEvIHgRsFdSJMTTZlpajJT9e1NbcGdrg4cvv8_hw-hY4LHBBN-Nhsb59KYYszLYoyx2EIjIgWtJVVsG40KpGqG1cse2s95hjGhguNdtEcEkVIINUIXT_Ez2NjG12BNW8UlpGWAjyr6KnSLIYU-QK7CvFq8mdQZC0P_Ay5SdIPt8yHa8abNcLSZB-j55vrp6q5-eLy9v7p8qC0jvK89mXoxMUxKZilvMAgw0imlKGHTpmmEIpJzLw12BKhvuGDeAqaKOMO8cZMDdLruLYffB8i97kK20LZmDnHIejIhijOl_gUppg0ubxSQrkGbYs4JvF6k0Jn0pQnWK796pld-9crvalf8ltDJpn2YduB-IxuhBThfA1BkFJNJZxtgbsGFBLbXLoa_-r8BpUKMPQ</recordid><startdate>20070110</startdate><enddate>20070110</enddate><creator>Jacobson-Kram, David</creator><creator>McGovern, Timothy</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>7U5</scope><scope>L7M</scope></search><sort><creationdate>20070110</creationdate><title>Toxicological overview of impurities in pharmaceutical products</title><author>Jacobson-Kram, David ; McGovern, Timothy</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c416t-f1bf73a4884c2650e7ea8d999214b555791866f8a0d1e2f5674fce0291da4fad3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Drug Contamination</topic><topic>Europe</topic><topic>European Medicines Agency (EMEA)</topic><topic>Genotoxic impurities</topic><topic>Guidelines as Topic</topic><topic>Humans</topic><topic>International Cooperation</topic><topic>Mutagens - analysis</topic><topic>Mutagens - toxicity</topic><topic>Pharmaceutical impurities</topic><topic>Pharmaceutical Preparations - analysis</topic><topic>Risk Assessment</topic><topic>Toxicology</topic><topic>United States</topic><topic>United States Food and Drug Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jacobson-Kram, David</creatorcontrib><creatorcontrib>McGovern, Timothy</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Solid State and Superconductivity Abstracts</collection><collection>Advanced Technologies Database with Aerospace</collection><jtitle>Advanced drug delivery reviews</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jacobson-Kram, David</au><au>McGovern, Timothy</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Toxicological overview of impurities in pharmaceutical products</atitle><jtitle>Advanced drug delivery reviews</jtitle><addtitle>Adv Drug Deliv Rev</addtitle><date>2007-01-10</date><risdate>2007</risdate><volume>59</volume><issue>1</issue><spage>38</spage><epage>42</epage><pages>38-42</pages><issn>0169-409X</issn><eissn>1872-8294</eissn><abstract>While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to the lowest levels that are reasonably practical, it is acknowledged that impurities cannot be reduced to zero and specifications for impurities need to be established. This chapter discusses practical and theoretical methods for qualification of different classes of impurities.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>17188779</pmid><doi>10.1016/j.addr.2006.10.007</doi><tpages>5</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0169-409X |
| ispartof | Advanced drug delivery reviews, 2007-01, Vol.59 (1), p.38-42 |
| issn | 0169-409X 1872-8294 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_33196499 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Drug Contamination Europe European Medicines Agency (EMEA) Genotoxic impurities Guidelines as Topic Humans International Cooperation Mutagens - analysis Mutagens - toxicity Pharmaceutical impurities Pharmaceutical Preparations - analysis Risk Assessment Toxicology United States United States Food and Drug Administration |
| title | Toxicological overview of impurities in pharmaceutical products |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-16T18%3A03%3A42IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Toxicological%20overview%20of%20impurities%20in%20pharmaceutical%20products&rft.jtitle=Advanced%20drug%20delivery%20reviews&rft.au=Jacobson-Kram,%20David&rft.date=2007-01-10&rft.volume=59&rft.issue=1&rft.spage=38&rft.epage=42&rft.pages=38-42&rft.issn=0169-409X&rft.eissn=1872-8294&rft_id=info:doi/10.1016/j.addr.2006.10.007&rft_dat=%3Cproquest_cross%3E33196499%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=20250884&rft_id=info:pmid/17188779&rft_els_id=S0169409X06002742&rfr_iscdi=true |