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28 results for Heimbach,+Tycho

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Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs
Author / Creator:Wu, Di ; Sanghavi, Maitri ; Kollipara, Sivacharan ; Ahmed, Tausif ; Saini, Anuj K ; Heimbach, Tycho
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2023-02, Vol.40 (2), p.337-357
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Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective
Author / Creator:Riedmaier, Arian Emami ; DeMent, Kevin ; Huckle, James ; Bransford, Phil ; Stillhart, Cordula ; Lloyd, Richard ; Alluri, Ravindra ; Basu, Sumit ; Chen, Yuan ; Dhamankar, Varsha ; Dodd, Stephanie ; Kulkarni, Priyanka ; Olivares-Morales, Andrés ; Peng, Chi-Chi ; Pepin, Xavier ; Ren, Xiaojun ; Tran, Thuy ; Tistaert, Christophe ; Heimbach, Tycho ; Kesisoglou, Filippos ; Wagner, Christian ; Parrott, Neil
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2020-09, Vol.22 (6), p.123, Article 123
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Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives
Author / Creator:Suarez-Sharp, Sandra ; Lindahl, Anders ; Heimbach, Tycho ; Rostami-Hodjegan, Amin ; Bolger, Michael B. ; Ray Chaudhuri, Siladitya ; Hens, Bart
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2020-06, Vol.37 (6), p.95, Article 95
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Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report
Author / Creator:Wu, Fang ; Mousa, Youssef ; Raines, Kimberly ; Bode, Chris ; Tsang, Yu Chung ; Cristofoletti, Rodrigo ; Zhang, Hongling ; Heimbach, Tycho ; Fang, Lanyan ; Kesisoglou, Filippos ; Mitra, Amitava ; Polli, James ; Kim, Myong‐Jin ; Fan, Jianghong ; Zolnik, Banu S. ; Sun, Duxin ; Zhang, Yi ; Zhao, Liang
Publisher:United States: John Wiley & Sons, Inc
Journal title:CPT: pharmacometrics and systems pharmacology, 2023-05, Vol.12 (5), p.585-597
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Model‐Informed Drug Development for Everolimus Dosing Selection in Pediatric Infant Patients
Author / Creator:Combes, Francois Pierre ; Einolf, Heidi J. ; Coello, Neva ; Heimbach, Tycho ; He, Handan ; Grosch, Kai
Publisher:United States: John Wiley & Sons, Inc
Journal title:CPT: pharmacometrics and systems pharmacology, 2020-04, Vol.9 (4), p.230-237
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Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective
Author / Creator:Lin, Wen ; Chen, Yuan ; Unadkat, Jashvant D. ; Zhang, Xinyuan ; Wu, Di ; Heimbach, Tycho
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2022-08, Vol.39 (8), p.1701-1731
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Prodrugs: design and clinical applications
Author / Creator:Rautio, Jarkko ; Kumpulainen, Hanna ; Heimbach, Tycho ; Oliyai, Reza ; Oh, Dooman ; Järvinen, Tomi ; Savolainen, Jouko
Publisher:London: Nature Publishing Group UK
Journal title:Nature reviews. Drug discovery, 2008-03, Vol.7 (3), p.255-270
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Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future Outlook
Author / Creator:Kollipara, Sivacharan ; Friden, Markus ; Heimbach, Tycho ; Saha, Pratik ; De Backer, Jan ; Ahmed, Tausif ; Nicholas, Timothy
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2025-05, Vol.42 (5), p.785-794
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Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space
Author / Creator:Wang, Michael ; Heimbach, Tycho ; Zhu, Wei ; Wu, Di ; Reuter, Kevin G. ; Kesisoglou, Filippos
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2024-06, Vol.26 (4), p.69, Article 69
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Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions
Author / Creator:Cheng, Yi-Hsien ; Pal, Arindom ; Moody, Rebecca ; Heimbach, Tycho ; Lukacova, Viera ; Patel, Nikunjkumar ; Rullo, Gregory ; Xu, Yunming ; Ahmed, Tausif ; Kerwash, Essam ; Fang, Lanyan ; Wu, Fang
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2025-05, Vol.42 (5), p.753-763
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Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium “Long-Acting Injectables” Working Group
Author / Creator:Bauer, Andrea ; Berben, Philippe ; Chakravarthi, Sudhir S. ; Chattorraj, Sayantan ; Garg, Ashish ; Gourdon, Betty ; Heimbach, Tycho ; Huang, Ye ; Morrison, Christopher ; Mundhra, Deepak ; Palaparthy, Ramesh ; Saha, Pratik ; Siemons, Maxime ; Shaik, Naveed A. ; Shi, Yi ; Shum, Sara ; Thakral, Naveen K. ; Urva, Shweta ; Vargo, Ryan ; Koganti, Venkat R. ; Barrett, Stephanie E.
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2023-07, Vol.40 (7), p.1601-1631
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Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products
Author / Creator:Wu, Fang ; Mousa, Youssef ; Jereb, Rebeka ; Batchelor, Hannah ; Chakraborty, Sumon ; Heimbach, Tycho ; Stier, Ethan ; Kesisoglou, Filippos ; Kollipara, Sivacharan ; Zhang, Lei ; Zhao, Liang
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2024-01, Vol.26 (1), p.19, Article 19
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Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection
Author / Creator:Gajewska, Monika ; Blumenstein, Lars ; Kourentas, Alexandros ; Mueller-Zsigmondy, Martin ; Lorenzo, Sebastien ; Sinn, Angela ; Velinova, Maria ; Heimbach, Tycho
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2020-10, Vol.22 (6), p.134, Article 134
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Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary
Author / Creator:Tsakalozou, Eleftheria ; Mohamed, Mohamed-Eslam F. ; Polak, Sebastian ; Heimbach, Tycho
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2023-10, Vol.25 (6), p.96, Article 96
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Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13 A with the Advancements of Physiologically Based Pharmacokinetic Modeling
Author / Creator:Pal, Arindom ; Alam, Khondoker ; Stier, Ethan ; Heimbach, Tycho ; Cristofoletti, Rodrigo ; Al‐Gousous, Jozef ; Langguth, Peter ; Žakelj, Rebeka ; Ahmed, Tausif ; Almeida, Susana ; Fan, Jianghong ; Kolhatkar, Vidula ; Paixão, Paulo ; Rayeni, Mohan Krishna ; Zhang, Lei ; Wu, Fang
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2025-05, Vol.42 (5), p.835-845
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Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039
Author / Creator:Kourentas, Alexandros ; Gajewska, Monika ; Lin, Wen ; Dhareshwar, Sundeep S. ; Steib-Lauer, Caroline ; Kulkarni, Swarupa ; Hirsch, Stefan ; Heimbach, Tycho ; Mueller-Zsigmondy, Martin
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2023-02, Vol.25 (1), p.25, Article 25
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An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow
Author / Creator:Aburub, Aktham ; Chen, Yuan ; Chung, John ; Gao, Ping ; Good, David ; Hansmann, Simone ; Hawley, Michael ; Heimbach, Tycho ; Hingle, Martin ; Kesisoglou, Filippos ; Li, Rong ; Rose, John ; Tisaert, Christophe
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2022-05, Vol.24 (3), p.49, Article 49
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Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis
Author / Creator:Kesisoglou, Filippos ; Basu, Sumit ; Belubbi, Tejashree ; Bransford, Philip ; Chung, John ; Dodd, Stephanie ; Dolton, Michael ; Heimbach, Tycho ; Kulkarni, Priyanka ; Lin, Wen ; Moir, Andrea ; Parrott, Neil ; Pepin, Xavier ; Ren, Xiaojun ; Sharma, Pradeep ; Stamatopoulos, Konstantinos ; Tistaert, Christophe ; Vaidhyanathan, Shruthi ; Wagner, Christian ; Riedmaier, Arian Emami
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2023-06, Vol.25 (4), p.60, Article 60
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Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization
Author / Creator:Cheng, Yi-Hsien ; Thomas, Sherin ; Tsang, Yu Chung ; Almeida, Susana ; Ashraf, Muhammad ; Fotaki, Nikoletta ; Heimbach, Tycho ; Patel, Nikunjkumar ; Shah, Harshil ; Jiang, Xiaojian ; Kim, Myong-Jin ; Moody, Rebecca ; Rostami‐Hodjegan, Amin ; Singh, Romi ; Zhao, Liang ; Babiskin, Andrew ; Wu, Fang
Publisher:New York: Springer US
Journal title:Pharmaceutical research, 2025-05, Vol.42 (5), p.819-833
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Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization
Author / Creator:Abend, Andreas M. ; Hoffelder, Thomas ; Cohen, Michael J. ; Van Alstine, Leslie ; Diaz, Dorys Argelia ; Fredro-Kumbaradzi, Emilija ; Reynolds, James ; Zheng, Yanbing ; Witkowski, Krista ; Heimbach, Tycho
Publisher:Cham: Springer International Publishing
Journal title:The AAPS journal, 2023-04, Vol.25 (3), p.44, Article 44
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Showing 1 to 20 of 28 results

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Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs

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Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective

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Translational Modeling Strategies for Orally Administered Drug Products: Academic, Industrial and Regulatory Perspectives

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Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

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Model‐Informed Drug Development for Everolimus Dosing Selection in Pediatric Infant Patients

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Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective

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Prodrugs: design and clinical applications

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Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future Outlook

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Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space

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Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions

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Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium “Long-Acting Injectables” Working Group

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Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products

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Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection

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Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

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Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13 A with the Advancements of Physiologically Based Pharmacokinetic Modeling

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Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039

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An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow

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Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis

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Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization

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Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization

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