157 related articles for article (PubMed ID: 38043684)
1. Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives.
Kollipara S; Martins FS; Sanghavi M; Santos GML; Saini A; Ahmed T
J Pharm Sci; 2024 Feb; 113(2):345-358. PubMed ID: 38043684
[TBL] [Abstract][Full Text] [Related]
2. Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs.
Wu D; Sanghavi M; Kollipara S; Ahmed T; Saini AK; Heimbach T
Pharm Res; 2023 Feb; 40(2):337-357. PubMed ID: 35840856
[TBL] [Abstract][Full Text] [Related]
3. Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Mitra A; Suarez-Sharp S; Pepin XJH; Flanagan T; Zhao Y; Kotzagiorgis E; Parrott N; Sharan S; Tistaert C; Heimbach T; Zolnik B; Sjögren E; Wu F; Anand O; Kakar S; Li M; Veerasingham S; Kijima S; Lima Santos GM; Ning B; Raines K; Rullo G; Mandula H; Delvadia P; Dressman J; Dickinson PA; Babiskin A
J Pharm Sci; 2021 Feb; 110(2):594-609. PubMed ID: 33152375
[TBL] [Abstract][Full Text] [Related]
4. Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM).
Jereb R; Kristl A; Mitra A
Eur J Pharm Sci; 2020 Dec; 155():105554. PubMed ID: 32946959
[TBL] [Abstract][Full Text] [Related]
5. Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space.
Bhattiprolu AK; Kollipara S; Ahmed T; Boddu R; Chachad S
J Pharm Sci; 2022 Dec; 111(12):3397-3410. PubMed ID: 36096285
[TBL] [Abstract][Full Text] [Related]
6. Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space.
Miranda Dos Santos E; Ferraz HG; Issa MG; Duque MD
J Pharm Sci; 2023 Dec; 112(12):3131-3140. PubMed ID: 37473918
[TBL] [Abstract][Full Text] [Related]
7. Integration of artificial neural network and physiologically based biopharmaceutic models in the development of sustained-release formulations.
Severino Martins F; Borges L; Oliveira do Couto R; Schaller S; de Freitas O
Biopharm Drug Dispos; 2023 Aug; 44(4):335-343. PubMed ID: 37649136
[TBL] [Abstract][Full Text] [Related]
8. Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective.
Kollipara S; Bhattiprolu AK; Boddu R; Ahmed T; Chachad S
AAPS PharmSciTech; 2023 Feb; 24(2):59. PubMed ID: 36759492
[TBL] [Abstract][Full Text] [Related]
9. Towards Virtual Bioequivalence Studies for Oral Dosage Forms Containing Poorly Water-Soluble Drugs: A Physiologically Based Biopharmaceutics Modeling (PBBM) Approach.
Kambayashi A; Dressman JB
J Pharm Sci; 2022 Jan; 111(1):135-145. PubMed ID: 34390740
[TBL] [Abstract][Full Text] [Related]
10. The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives.
Anand O; Pepin XJH; Kolhatkar V; Seo P
Pharm Res; 2022 Aug; 39(8):1681-1700. PubMed ID: 35585448
[TBL] [Abstract][Full Text] [Related]
11. Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies.
Heimbach T; Kesisoglou F; Novakovic J; Tistaert C; Mueller-Zsigmondy M; Kollipara S; Ahmed T; Mitra A; Suarez-Sharp S
J Pharm Sci; 2021 Dec; 110(12):3896-3906. PubMed ID: 34551349
[TBL] [Abstract][Full Text] [Related]
12. Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space.
Wang M; Heimbach T; Zhu W; Wu D; Reuter KG; Kesisoglou F
AAPS J; 2024 Jun; 26(4):69. PubMed ID: 38862807
[TBL] [Abstract][Full Text] [Related]
13. Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions.
Boddu R; Kollipara S; Vijaywargi G; Ahmed T
Xenobiotica; 2023 Apr; 53(4):260-278. PubMed ID: 37471259
[TBL] [Abstract][Full Text] [Related]
14. Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.
Ahmed T; Kollipara S; Boddu R; Bhattiprolu AK
AAPS J; 2023 Jul; 25(5):77. PubMed ID: 37498474
[TBL] [Abstract][Full Text] [Related]
15. Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption.
Laisney M; Heimbach T; Mueller-Zsigmondy M; Blumenstein L; Costa R; Ji Y
J Pharm Sci; 2022 Jan; 111(1):274-284. PubMed ID: 34678270
[TBL] [Abstract][Full Text] [Related]
16. Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.
Parrott N; Suarez-Sharp S; Kesisoglou F; Pathak SM; Good D; Wagner C; Dallmann A; Mullin J; Patel N; Riedmaier AE; Mitra A; Raines K; Butler J; Kakhi M; Li M; Zhao Y; Tsakalozou E; Flanagan T; Dressman J; Pepin X
J Pharm Sci; 2021 Feb; 110(2):584-593. PubMed ID: 33058891
[TBL] [Abstract][Full Text] [Related]
17. Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling.
García MA; Bolger MB; Suarez-Sharp S; Langguth P
J Pharm Sci; 2022 Jan; 111(1):262-273. PubMed ID: 34678271
[TBL] [Abstract][Full Text] [Related]
18. Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.
Pepin X; Arora S; Borges L; Cano-Vega M; Carducci T; Chatterjee P; Chen G; Cristofoletti R; Dallmann A; Delvadia P; Dressman J; Fotaki N; Gray E; Heimbach T; Holte Ø; Kijima S; Kotzagiorgis E; Lennernäs H; Lindahl A; Loebenberg R; Mackie C; Malamatari M; McAllister M; Mitra A; Moody R; Mudie D; Musuamba Tshinanu F; Polli JE; Rege B; Ren X; Rullo G; Scherholz M; Song I; Stillhart C; Suarez-Sharp S; Tannergren C; Tsakalozou E; Veerasingham S; Wagner C; Seo P
Mol Pharm; 2024 Jun; ():. PubMed ID: 38946085
[TBL] [Abstract][Full Text] [Related]
19. A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation.
Aishwarya R; Murthy A; Ahmed T; Chachad S
J Pharm Sci; 2022 Jun; 111(6):1820-1832. PubMed ID: 35217007
[TBL] [Abstract][Full Text] [Related]
20. Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development.
Wu D; Li M
Pharm Res; 2023 Feb; 40(2):321-336. PubMed ID: 36076007
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]