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Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
Zamiri C, Leiske DL, Hughes P, Kirwan JP, Der E, Cox E, Warburton R, Goss M, Weiser S, Perez-Brown J, Gopalrathnam G, Liu J, Mehta SB, Shereefa S, Specht S, Aedo SJ, Goldbach P, Jia F, Kuehnle B, Page S, Voeten L, Yi L, Zhu C. Zamiri C, et al. Among authors: specht s. PDA J Pharm Sci Technol. 2024 Aug 23;78(4):475-500. doi: 10.5731/pdajpst.2022.012806. PDA J Pharm Sci Technol. 2024. PMID: 37848203
ICH: Strengths, Weaknesses, and Future Tasks.
Specht S, Klingmann I. Specht S, et al. Ther Innov Regul Sci. 2014 May;48(3):357-361. doi: 10.1177/2168479013520161. Ther Innov Regul Sci. 2014. PMID: 30235539
Efficacy and safety of gene therapy with onasemnogene abeparvovec in children with spinal muscular atrophy in the D-A-CH-region: a population-based observational study.
Weiß C, Becker LL, Friese J, Blaschek A, Hahn A, Illsinger S, Schwartz O, Bernert G, Hagen MV, Husain RA, Goldhahn K, Kirschner J, Pechmann A, Flotats-Bastardas M, Schreiber G, Schara U, Plecko B, Trollmann R, Horber V, Wilichowski E, Baumann M, Klein A, Eisenkölbl A, Köhler C, Stettner GM, Cirak S, Hasselmann O, Kaindl AM, Garbade SF, Johannsen J, Ziegler A; SMArtCARE and Swiss-Reg-NMD study group. Weiß C, et al. Lancet Reg Health Eur. 2024 Oct 7;47:101092. doi: 10.1016/j.lanepe.2024.101092. eCollection 2024 Dec. Lancet Reg Health Eur. 2024. PMID: 39434961 Free PMC article.
Clinical Effectiveness of Newborn Screening for Spinal Muscular Atrophy: A Nonrandomized Controlled Trial.
Schwartz O, Vill K, Pfaffenlehner M, Behrens M, Weiß C, Johannsen J, Friese J, Hahn A, Ziegler A, Illsinger S, Smitka M, von Moers A, Kölbel H, Schreiber G, Kaiser N, Wilichowski E, Flotats-Bastardas M, Husain RA, Baumann M, Köhler C, Trollmann R, Schwerin-Nagel A, Eisenkölbl A, Schimmel M, Fleger M, Kauffmann B, Wiegand G, Baumgartner M, Rauscher C, Cirak S, Gläser D, Bernert G, Hagenacker T, Goldbach S, Probst-Schendzielorz K, Lochmüller H, Müller-Felber W, Schara-Schmidt U, Walter MC, Kirschner J, Pechmann A; SMARTCARE study group. Schwartz O, et al. JAMA Pediatr. 2024 Jun 1;178(6):540-547. doi: 10.1001/jamapediatrics.2024.0492. JAMA Pediatr. 2024. PMID: 38587854 Clinical Trial.
Variants in the WDR44 WD40-repeat domain cause a spectrum of ciliopathy by impairing ciliogenesis initiation.
Accogli A, Shakya S, Yang T, Insinna C, Kim SY, Bell D, Butov KR, Severino M, Niceta M, Scala M, Lee HS, Yoo T, Stauffer J, Zhao H, Fiorillo C, Pedemonte M, Diana MC, Baldassari S, Zakharova V, Shcherbina A, Rodina Y, Fagerberg C, Roos LS, Wierzba J, Dobosz A, Gerard A, Potocki L, Rosenfeld JA, Lalani SR, Scott TM, Scott D, Azamian MS, Louie R, Moore HW, Champaigne NL, Hollingsworth G, Torella A, Nigro V, Ploski R, Salpietro V, Zara F, Pizzi S, Chillemi G, Ognibene M, Cooney E, Do J, Linnemann A, Larsen MJ, Specht S, Walters KJ, Choi HJ, Choi M, Tartaglia M, Youkharibache P, Chae JH, Capra V, Park SG, Westlake CJ. Accogli A, et al. Among authors: specht s. Nat Commun. 2024 Jan 8;15(1):365. doi: 10.1038/s41467-023-44611-2. Nat Commun. 2024. PMID: 38191484 Free PMC article.
Asteatotic Eczema.
Specht S, Persaud Y. Specht S, et al. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan–. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan–. PMID: 31747214 Free Books & Documents.
Biodegradable, Self-Reinforcing Vascular Grafts for In Situ Tissue Engineering Approaches.
Rohringer S, Grasl C, Ehrmann K, Hager P, Hahn C, Specht SJ, Walter I, Schneider KH, Zopf LM, Baudis S, Liska R, Schima H, Podesser BK, Bergmeister H. Rohringer S, et al. Among authors: specht sj. Adv Healthc Mater. 2023 Sep;12(23):e2300520. doi: 10.1002/adhm.202300520. Epub 2023 May 21. Adv Healthc Mater. 2023. PMID: 37173073 Free PMC article.
Perspective on Schistosomiasis Drug Discovery: Highlights from a Schistosomiasis Drug Discovery Workshop at Wellcome Collection, London, September 2022.
Caldwell N, Afshar R, Baragaña B, Bustinduy AL, Caffrey CR, Collins JJ, Fusco D, Garba A, Gardner M, Gomes M, Hoffmann KF, Hsieh M, Lo NC, McNamara CW, Nono JK, Padalino G, Read KD, Roestenberg M, Spangenberg T, Specht S, Gilbert IH. Caldwell N, et al. Among authors: specht s. ACS Infect Dis. 2023 May 12;9(5):1046-1055. doi: 10.1021/acsinfecdis.3c00081. Epub 2023 Apr 21. ACS Infect Dis. 2023. PMID: 37083395 Free PMC article. Review.
243 results