These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
234 related articles for article (PubMed ID: 30244011)
1. Commentary on Fit-For-Purpose Models for Regulatory Applications. Wang Y; Huang SM J Pharm Sci; 2019 Jan; 108(1):18-20. PubMed ID: 30244011 [TBL] [Abstract][Full Text] [Related]
2. Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Grimstein M; Yang Y; Zhang X; Grillo J; Huang SM; Zineh I; Wang Y J Pharm Sci; 2019 Jan; 108(1):21-25. PubMed ID: 30385284 [TBL] [Abstract][Full Text] [Related]
4. Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Zhao P; Rowland M; Huang SM Clin Pharmacol Ther; 2012 Jul; 92(1):17-20. PubMed ID: 22713733 [TBL] [Abstract][Full Text] [Related]
5. Model-Informed Drug Development: Current US Regulatory Practice and Future Considerations. Wang Y; Zhu H; Madabushi R; Liu Q; Huang SM; Zineh I Clin Pharmacol Ther; 2019 Apr; 105(4):899-911. PubMed ID: 30653670 [TBL] [Abstract][Full Text] [Related]
6. Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology. Zhang X; Yang Y; Grimstein M; Fan J; Grillo JA; Huang SM; Zhu H; Wang Y J Clin Pharmacol; 2020 Oct; 60 Suppl 1():S160-S178. PubMed ID: 33205429 [TBL] [Abstract][Full Text] [Related]
7. Integration of Engineered Delivery with the Pharmacokinetics of Medical Candidates via Physiology-Based Pharmacokinetics. Yang Y; Zhang X Methods Mol Biol; 2022; 2486():57-69. PubMed ID: 35437718 [TBL] [Abstract][Full Text] [Related]
8. Impact of Physiologically Based Pharmacokinetics, Population Pharmacokinetics and Pharmacokinetics/Pharmacodynamics in the Development of Antibody-Drug Conjugates. Li C; Chen SC; Chen Y; Girish S; Kaagedal M; Lu D; Lu T; Samineni D; Jin JY J Clin Pharmacol; 2020 Oct; 60 Suppl 1(Suppl 1):S105-S119. PubMed ID: 33205423 [TBL] [Abstract][Full Text] [Related]
9. Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice. Johnson TN; Rostami-Hodjegan A Paediatr Anaesth; 2011 Mar; 21(3):291-301. PubMed ID: 20497354 [TBL] [Abstract][Full Text] [Related]
10. Industry Perspective on Using MIDD for Pediatric Studies Requiring Integration of Ontogeny. Corriol-Rohou S; Cheung SYA J Clin Pharmacol; 2019 Sep; 59 Suppl 1():S112-S119. PubMed ID: 31502694 [TBL] [Abstract][Full Text] [Related]
11. Physiological-based pharmacokinetic modeling trends in pharmaceutical drug development over the last 20-years; in-depth analysis of applications, organizations, and platforms. El-Khateeb E; Burkhill S; Murby S; Amirat H; Rostami-Hodjegan A; Ahmad A Biopharm Drug Dispos; 2021 Apr; 42(4):107-117. PubMed ID: 33325034 [TBL] [Abstract][Full Text] [Related]
12. Opportunities and challenges for applying model-informed drug development approaches to gene therapies. Belov A; Schultz K; Forshee R; Tegenge MA CPT Pharmacometrics Syst Pharmacol; 2021 Apr; 10(4):286-290. PubMed ID: 33608998 [TBL] [Abstract][Full Text] [Related]
13. Transitioning from Basic toward Systems Pharmacodynamic Models: Lessons from Corticosteroids. Ayyar VS; Jusko WJ Pharmacol Rev; 2020 Apr; 72(2):414-438. PubMed ID: 32123034 [TBL] [Abstract][Full Text] [Related]
14. Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: a marriage under the arch of systems pharmacology. Rostami-Hodjegan A Clin Pharmacol Ther; 2012 Jul; 92(1):50-61. PubMed ID: 22644330 [TBL] [Abstract][Full Text] [Related]
15. The role of physiologically based pharmacokinetic modeling in regulatory review. Huang SM; Rowland M Clin Pharmacol Ther; 2012 Mar; 91(3):542-9. PubMed ID: 22318616 [TBL] [Abstract][Full Text] [Related]
16. Physiologically based pharmacokinetic (PBPK) modeling and simulation in neonatal drug development: how clinicians can contribute. Smits A; De Cock P; Vermeulen A; Allegaert K Expert Opin Drug Metab Toxicol; 2019 Jan; 15(1):25-34. PubMed ID: 30554542 [No Abstract] [Full Text] [Related]
17. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Zhao P; Zhang L; Grillo JA; Liu Q; Bullock JM; Moon YJ; Song P; Brar SS; Madabushi R; Wu TC; Booth BP; Rahman NA; Reynolds KS; Gil Berglund E; Lesko LJ; Huang SM Clin Pharmacol Ther; 2011 Feb; 89(2):259-67. PubMed ID: 21191381 [TBL] [Abstract][Full Text] [Related]
18. State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development. Yellepeddi V; Rower J; Liu X; Kumar S; Rashid J; Sherwin CMT Clin Pharmacokinet; 2019 Jan; 58(1):1-13. PubMed ID: 29777528 [TBL] [Abstract][Full Text] [Related]
19. Quality Assurance of PBPK Modeling Platforms and Guidance on Building, Evaluating, Verifying and Applying PBPK Models Prudently under the Umbrella of Qualification: Why, When, What, How and By Whom? Frechen S; Rostami-Hodjegan A Pharm Res; 2022 Aug; 39(8):1733-1748. PubMed ID: 35445350 [TBL] [Abstract][Full Text] [Related]
20. Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence: a PEARRL review. Loisios-Konstantinidis I; Paraiso RLM; Fotaki N; McAllister M; Cristofoletti R; Dressman J J Pharm Pharmacol; 2019 Apr; 71(4):699-723. PubMed ID: 30793317 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]