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Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Mackie C, Arora S, Seo P, Moody R, Rege B, Pepin X, Heimbach T, Tannergren C, Mitra A, Suarez-Sharp S, Borges LN, Kijima S, Kotzagiorgis E, Malamatari M, Veerasingham S, Polli JE, Rullo G. Mackie C, et al. Among authors: heimbach t. Mol Pharm. 2024 May 6;21(5):2065-2080. doi: 10.1021/acs.molpharmaceut.4c00202. Epub 2024 Apr 10. Mol Pharm. 2024. PMID: 38600804 Free PMC article. Review.
Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
Wu F, Mousa Y, Raines K, Bode C, Tsang YC, Cristofoletti R, Zhang H, Heimbach T, Fang L, Kesisoglou F, Mitra A, Polli J, Kim MJ, Fan J, Zolnik BS, Sun D, Zhang Y, Zhao L. Wu F, et al. Among authors: heimbach t. CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):585-597. doi: 10.1002/psp4.12907. Epub 2023 Jan 4. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 36530026 Free PMC article. Review.
Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium "Long-Acting Injectables" Working Group.
Bauer A, Berben P, Chakravarthi SS, Chattorraj S, Garg A, Gourdon B, Heimbach T, Huang Y, Morrison C, Mundhra D, Palaparthy R, Saha P, Siemons M, Shaik NA, Shi Y, Shum S, Thakral NK, Urva S, Vargo R, Koganti VR, Barrett SE. Bauer A, et al. Among authors: heimbach t. Pharm Res. 2023 Jul;40(7):1601-1631. doi: 10.1007/s11095-022-03391-y. Epub 2023 Feb 22. Pharm Res. 2023. PMID: 36811809 Review.
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial of Radiopaque Islatravir-Eluting Subdermal Implants for Pre-exposure Prophylaxis Against HIV-1 Infection.
Matthews RP, Zang X, Barrett SE, Koynov A, Goodey A, Heimbach T, Weissler VL, Leyssens C, Reynders T, Xu Z, Rottey S, Vargo R, Robertson MN, Stoch SA, Iwamoto M. Matthews RP, et al. Among authors: heimbach t. J Acquir Immune Defic Syndr. 2023 Apr 1;92(4):310-316. doi: 10.1097/QAI.0000000000003135. Epub 2022 Nov 29. J Acquir Immune Defic Syndr. 2023. PMID: 36450129 Free PMC article. Clinical Trial.
Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.
Kesisoglou F, Basu S, Belubbi T, Bransford P, Chung J, Dodd S, Dolton M, Heimbach T, Kulkarni P, Lin W, Moir A, Parrott N, Pepin X, Ren X, Sharma P, Stamatopoulos K, Tistaert C, Vaidhyanathan S, Wagner C, Riedmaier AE. Kesisoglou F, et al. Among authors: heimbach t. AAPS J. 2023 Jun 15;25(4):60. doi: 10.1208/s12248-023-00822-5. AAPS J. 2023. PMID: 37322223
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