Results 131 to 140 of about 781 (182)

Biopharmaceutics classification system (BCS)-based biowaiver for immediate release solid oral dosage forms of moxifloxacin hydrochloride (Moxiflox GPO) manufactured by the Government Pharmaceutical Organization (GPO)

Asian Journal of Pharmaceutical Sciences, 2016
Nawaphon Saelim, Khemjira Suksawaeng, Jutamat Chupan, Isariya Techatanawat   +3 more
doaj   +1 more source

Virtual bioequivalence-guided PBBM prediction for ibuprofen/diphenhydramine citrate tablets: impact of dissolution variability and clinical standard development. [PDF]

Saudi Pharm J
Wang Z, Cao Z, Guo C, Zhang Q, Zhou R, Chen J, Su F, Liu W, Chu Z, Zheng L, Hu W.   +10 more
europepmc   +1 more source

Application of New Approach Methodologies to Improve Oral Biopharmaceutic Assessments. [PDF]

Pharmaceutics
García MA, Cabrera-Pérez MÁ, González PM, Aceituno A, Hachim D.   +4 more
europepmc   +1 more source

Endeavoring Biowaivers using IVIVC: shifting paradigms

Journal of Bioequivalence & Bioavailability, 2010
openaire   +1 more source

Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects. [PDF]

BMC Med Res Methodol
Althunian TA, Alzenaidy BR, Alroba RA, Almadani OA, Alqahtani FA, Binajlan AA, Almousa AI, Alamr DK, Al-Mofada MS, Alsaqer NY, Alarfaj HA, Bahlewa AA, Alharbi MA, Alhomaidan AM, Alsuwyeh AA, Alsaleh AA.   +15 more
europepmc   +1 more source

Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report. [PDF]

Mol Pharm
Tannergren C, Arora S, Babiskin A, Borges L, Chatterjee P, Cheng YH, Dallmann A, Govada A, Heimbach T, Hingle M, Kollipara S, Kotzagiorgis E, Lindahl A, Mackie C, Malamatari M, Mitra A, Moody R, Pepin X, Polli J, Raines K, Rullo G, Sanghavi M, Savkur R, Singh R, Sjögren E, Suarez-Sharp S, Thomas S, Veerasingham S, Wei K, Wu F, Xu Y, Yoon M, Rege B.   +32 more
europepmc   +1 more source

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. [PDF]

Mol Pharm
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.   +16 more
europepmc   +1 more source

PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report. [PDF]

Mol Pharm
Heimbach T, Musuamba Tshinanu F, Raines K, Borges L, Kijima S, Malamatari M, Moody R, Veerasingham S, Seo P, Turner D, Fang L, Stillhart C, Bransford P, Ren X, Patel N, Sperry D, Chen H, Rostami-Hodjegan A, Lukacova V, Sun D, Nguefack JF, Carducci T, Grimstein M, Pepin X, Jamei M, Stamatopoulos K, Li M, Sanghavi M, Tannergren C, Mandula H, Zhao Z, Ju TR, Wagner C, Arora S, Wang M, Rullo G, Mitra A, Kollipara S, Chirumamilla SK, Polli JE, Mackie C.   +40 more
europepmc   +1 more source

Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions. [PDF]

Mol Pharm
Arora S, Pepin X, Jamei M, Sharma P, Heimbach T, Wagner C, Bransford P, Kollipara S, Ahmed T, Hingle M, Dallmann A, Scherholz M, Stamatis SD, Cano-Vega M, Mistry N, Tannergren C, Borges L, Lindahl A, Rullo G, Mackie C, Mitra A, Kushner J, Harish Jain KM, Polli JE.   +23 more
europepmc   +1 more source

Biopharmaceutical Profiling of Herpetrione: A BCS II Properties and P-gp Substrate Guiding Nanoparticle Design. [PDF]

Pharmaceutics
Wang F, Deng X, Zhu Y, Zong X, Ma Y, Yuan H.   +5 more
europepmc   +1 more source