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FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply.
Almeter PJ, Isaacs JT, Hunter AN, Henderson BS, Platt T, Mitchell BJ, Do D, Brainard AB, Brown JE, Stone RM, Nguyen BH, Warren MF, Bhaktawara SA, Bossle MN, Long LM, Zapata SP, Larkin CR, Lyman TA, Larkin SA, Labuhn JA, Reynolds JW, Schuler EE, Naseman RW, Johnson GL, Lodder RA. Almeter PJ, et al. Among authors: hunter an. J Pharm Innov. 2022;17(2):269-282. doi: 10.1007/s12247-022-09659-5. Epub 2022 Jun 3. J Pharm Innov. 2022. PMID: 35677914 Free PMC article. Review.
Intra-Lot and Inter-Lot Variability in Cosyntropin.
Almeter PJ, Isaacs JT, Hunter AN, Henderson BS, Lodder RA. Almeter PJ, et al. Among authors: hunter an. Contact Context. 2021;2021:10.6084/m9.figshare.17363048. doi: 10.6084/m9.figshare.17363048. Epub 2021 Dec 22. Contact Context. 2021. PMID: 35035309 Free PMC article.
Spectrometric Results of Process Variations in Dacarbazine.
Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, Lodder RA. Isaacs JT, et al. Among authors: hunter an. Contact Context. 2022;2022:10.6084/m9.figshare.17868614. doi: 10.6084/m9.figshare.17868614. Epub 2022 Jan 4. Contact Context. 2022. PMID: 35035310 Free PMC article.
FTNIR Spectrometry of Micafungin Sodium Quality.
Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, Lodder RA. Isaacs JT, et al. Among authors: hunter an. Contact Context. 2022;2022:10.6084/m9.figshare.19071704. doi: 10.6084/m9.figshare.19071704. Epub 2022 Jan 26. Contact Context. 2022. PMID: 35360460 Free PMC article.
Lack of Content Uniformity in MMR Vaccine.
Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, Lodder RA. Isaacs JT, et al. Among authors: hunter an. Contact Context. 2022;2022:10.6084/m9.figshare.19217478. doi: 10.6084/m9.figshare.19217478. Epub 2022 Feb 22. Contact Context. 2022. PMID: 35360461 Free PMC article.
Intra-Lot and Inter-Lot Variability in Ceftaroline Fosamil.
Almeter PJ, Isaacs JT, Hunter AN, Henderson BS, Lodder RA. Almeter PJ, et al. Among authors: hunter an. Contact Context. 2021;2021:10.6084/m9.figshare.17292596. doi: 10.6084/m9.figshare.17292596. Epub 2021 Dec 19. Contact Context. 2021. PMID: 35360663 Free PMC article.
Levothyroxine Variations by Process Analytical Technology.
Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, Lodder RA. Isaacs JT, et al. Among authors: hunter an. Contact Context. 2022;2022:10.6084/m9.figshare.18316523. doi: 10.6084/m9.figshare.18316523. Epub 2022 Apr 12. Contact Context. 2022. PMID: 35440917 Free PMC article.
Variability in Content of Piperacillin and Tazobactam Injection.
Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, Lodder RA. Isaacs JT, et al. Among authors: hunter an. Contact Context. 2022;2022:10.6084/m9.figshare.19561333. doi: 10.6084/m9.figshare.19561333. Epub 2022 Dec 4. Contact Context. 2022. PMID: 35506061 Free PMC article.
Potential Process Control Issues with Pemetrexed.
Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, Lodder RA. Isaacs JT, et al. Among authors: hunter an. Contact Context. 2022;2022:10.6084/m9.figshare.20245158. doi: 10.6084/m9.figshare.20245158. Epub 2022 Jul 6. Contact Context. 2022. PMID: 35967958 Free PMC article.
Spectrometric Analysis of Process Variations in Remifentanil.
Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, Lodder RA. Isaacs JT, et al. Among authors: hunter an. Contact Context. 2022;2022:10.6084/m9.figshare.21109093. doi: 10.6084/m9.figshare.21109093. Epub 2022 Sep 14. Contact Context. 2022. PMID: 36187755 Free PMC article.
28 results