Contact in contextPub Date : 2022-01-01Epub Date: 2022-01-04DOI: 10.6084/m9.figshare.17868614
James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Robert A Lodder
{"title":"Spectrometric Results of Process Variations in Dacarbazine.","authors":"James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Robert A Lodder","doi":"10.6084/m9.figshare.17868614","DOIUrl":"https://doi.org/10.6084/m9.figshare.17868614","url":null,"abstract":"<p><p>Intra-lot and inter-lot variability in dacarbazine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of six vials sampled from Fresenius Kabi Lot 6125612 appeared 7.8 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 54 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.</p>","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":"2022 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8758066/pdf/nihms-1768830.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39825145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Contact in contextPub Date : 2022-01-01DOI: 10.6084/m9.figshare.18316523
James T. Isaacs, Philip J. Almeter, Bradley S. Henderson, Aaron N. Hunter, Thomas L. Platt, R. Lodder
{"title":"Levothyroxine Variations by Process Analytical Technology.","authors":"James T. Isaacs, Philip J. Almeter, Bradley S. Henderson, Aaron N. Hunter, Thomas L. Platt, R. Lodder","doi":"10.6084/m9.figshare.18316523","DOIUrl":"https://doi.org/10.6084/m9.figshare.18316523","url":null,"abstract":"Intra-lot and inter-lot variability in the spectra of levothyroxine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). Two vials of 12 vials sampled from Athenex lot AFN102 appeared 10.1 and 9.1 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 108 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":"79 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78441672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Contact in contextPub Date : 2022-01-01Epub Date: 2022-07-06DOI: 10.6084/m9.figshare.20245158
James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Robert A Lodder
{"title":"Potential Process Control Issues with Pemetrexed.","authors":"James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Robert A Lodder","doi":"10.6084/m9.figshare.20245158","DOIUrl":"https://doi.org/10.6084/m9.figshare.20245158","url":null,"abstract":"<p><p>Pemetrexed is a folate analog metabolic inhibitor used in treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer and for mesothelioma. Intra-lot and inter-lot variability in the spectra of ALIMTA® was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of 12 (8%) sampled from lot S20I013A appeared 3.0 multidimensional SDs from the other vials, suggesting that it represents a different material. Consequently, additional spectra from other lots were analyzed. Spectra of 147 vials from 23 lots in the spectral library contained 14 vials that were outside the main group (26.4 SDs using a subcluster detection test), suggesting that the 14 library vials (9.5% of the total) also contain differing materials.</p>","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9367643/pdf/nihms-1825494.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40615110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Contact in contextPub Date : 2022-01-01DOI: 10.6084/m9.figshare.19561333
James T. Isaacs, Philip J. Almeter, Bradley S. Henderson, Aaron N. Hunter, Thomas L. Platt, R. Lodder
{"title":"Variability in Content of Piperacillin and Tazobactam Injection.","authors":"James T. Isaacs, Philip J. Almeter, Bradley S. Henderson, Aaron N. Hunter, Thomas L. Platt, R. Lodder","doi":"10.6084/m9.figshare.19561333","DOIUrl":"https://doi.org/10.6084/m9.figshare.19561333","url":null,"abstract":"Piperacillin and Tazobactam Injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a beta-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of bacteria. In the past decade some quality problems have been noted by the US Food and Drug Administration (FDA) with the Apotex Corp. manufacturing. Intra-lot and inter-lot variability in the spectra of Piperacillin and Tazobactam Injection 3.375 g was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of 6 (17%) sampled from lot AD103008F3 appeared 14.4 multidimensional SDs from the other vials, suggesting that it represents a different material. Spectra of 132 vials from 19 lots in the spectral library contained 4 vials that were outside the group (21.0 SDs using a subcluster detection test), suggesting that the 4 library vials (3%) also contain differing materials.","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88829829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Contact in contextPub Date : 2021-01-01Epub Date: 2021-12-22DOI: 10.6084/m9.figshare.17363048
Philip J Almeter, James T Isaacs, Aaron N Hunter, Bradley S Henderson, Robert A Lodder
{"title":"Intra-Lot and Inter-Lot Variability in Cosyntropin.","authors":"Philip J Almeter, James T Isaacs, Aaron N Hunter, Bradley S Henderson, Robert A Lodder","doi":"10.6084/m9.figshare.17363048","DOIUrl":"https://doi.org/10.6084/m9.figshare.17363048","url":null,"abstract":"<p><p>Intra-lot and inter-lot variability in cosyntropin was detected in the DQS using Fourier transform near-infrared spectrometry. One vial of 12 sampled from Sandoz Lot0200062 appeared 6.9 SDs from the center of the rest of the vials, and another was 4.3 SDs away. Spectra of 102 vials from 7 lots in the library clustered in two groups (p=0.02).</p>","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":"2021 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8758055/pdf/nihms-1766446.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39825144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Contact in contextPub Date : 2021-01-01DOI: 10.6084/m9.figshare.17292596
Philip J. Almeter, James T. Isaacs, Aaron N. Hunter, Bradley S. Henderson, R. Lodder
{"title":"Intra-Lot and Inter-Lot Variability in Ceftaroline Fosamil.","authors":"Philip J. Almeter, James T. Isaacs, Aaron N. Hunter, Bradley S. Henderson, R. Lodder","doi":"10.6084/m9.figshare.17292596","DOIUrl":"https://doi.org/10.6084/m9.figshare.17292596","url":null,"abstract":"Intra-lot and inter-lot variability in ceftaroline fosamil was detected in the DQS using Fourier transform near-infrared spectrometry. One vial of 18 sampled from Lot0013E06 appeared 9.0 SDs from the center of the rest of the vials. Six lots in the spectral library clustered in two large groups.","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":"70 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82203896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Contact in contextPub Date : 2021-01-01DOI: 10.6084/m9.figshare.16417218
Philip J Almeter, James T Isaacs, Erin E Schuler, Robert A Lodder
{"title":"Potential Process Control Issues with Remdesivir.","authors":"Philip J Almeter, James T Isaacs, Erin E Schuler, Robert A Lodder","doi":"10.6084/m9.figshare.16417218","DOIUrl":"https://doi.org/10.6084/m9.figshare.16417218","url":null,"abstract":"1. Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536 2. Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40506 3. Pathology & Laboratory Medicine, College of Medicine, University of Kentucky, Lexington, KY 40536 4. Department of Pharmaceutical Sciences, University of Kentucky, Lexington, KY 40536 *Author to whom correspondence should be addressed. Email: Lodder @ g.uky.edu","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":"2021 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679181/pdf/nihms-1644713.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39739769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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