Results 111 to 120 of about 1,942 (154)

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

Mastering particle size analysis: lessons, challenges, and future directions from the FDA-CRCG workshop. [PDF]

AAPS Open
Xu X, Smith WC, Polli JE, Plavchak CL, Qin B, Wang Y, Holtgrewe N, Raney SG, O'Reilly Beringhs A, Yu YB, Taraban M, Krishnan V, Schwendeman A, Hammell DC, Clogston JD, Rawle AF, Grmaš J, Ayoub Y, Domnic B, Reddy RS, Duncan J, McGann M, Bodycomb J, Schuurmans CCL, Hermes M, Mehtala JG, Roy P, Lance K, Britten C, Park K, Beach D, Elmer M, Rodenhausen KB, Xu Z, Qu H, Wu KW, Korang-Yeboah M, Zou Y, Li J, Abuznait AH, Quinn C, Ethier A, Ip K, Dhamecha D, Li Q, Zhu D, Valapil R.   +46 more
europepmc   +1 more source

Alternative ranking procedures: update [PDF]

Nicholas J. Cox
core   +4 more sources

Role of Pharmacogenetics on Tramadol Pharmacokinetics: A Population Pharmacokinetic Model. [PDF]

Eur J Drug Metab Pharmacokinet
Soria-Chacartegui P, Würthwein G, Zubiaur P, Almenara S, Ochoa D, Abad-Santos F, Hempel G.   +6 more
europepmc   +1 more source

Advancing drug development with "Fit-for-Purpose" modeling informed approaches. [PDF]

J Pharmacokinet Pharmacodyn
Sheng J, Zhang T.
europepmc   +1 more source

Integrating In Vitro BE Checker with In Silico Physiologically Based Biopharmaceutics Modeling to Predict the Pharmacokinetic Profiles of Oral Drug Products. [PDF]

Pharmaceutics
Niino T, Masada T, Takagi T, Kataoka M, Yoshida H, Yamashita S, Kambayashi A.   +6 more
europepmc   +1 more source

Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: A webinar summary. [PDF]

J Pharm Sci
Fang L, Veerasingham S, Xu Y, Garcia-Arieta A, Kollipara S, Kanagasabapathy Y, Ahmed T, Martins FS, Suarez-Sharp S.   +8 more
europepmc   +1 more source

Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin. [PDF]

J Pharm Sci
Negoya R, Tsueoka M, Sun X, Nishida S, Abrahamsson B, Charoo NA, Cristofoletti R, Langguth P, Mehta M, Parr A, Polli JE, Shah VP, Dressman J, Kambayashi A.   +13 more
europepmc   +1 more source

Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products. [PDF]

Pharm Res
Walenga RL, Chopski SG, Lee JH, Wang F, Hu M, Babiskin AH, Fang L, Zhao L.   +7 more
europepmc   +1 more source

Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model

The AAPS Journal
Anas Saadeddin, Vivek Purohit, Yeamin Huh, Mei Wong, Aurelia Maulny, Martin E. Dowty, Kazuko Sagawa   +6 more
openaire   +1 more source