Results 121 to 130 of about 781 (182)

A Bioequivalence Study Comparing Two Pomalidomide Hard Capsule Formulations in Healthy Chilean Subjects. [PDF]

Pharmaceuticals (Basel)
Davanço MG, Vespasiano TP, Moisan J, Gonzalez O, Sarmiento M, Groleau M.   +5 more
europepmc   +1 more source

Solubility of lamotrigine in age-specific biorelevant media that simulated the fasted- and fed-conditions of the gastric and intestinal environments in pediatrics and adults: implications for traditional, re-formulated, modified, and new oral formulations. [PDF]

BMC Biotechnol, 2023
Shawahna R, Saba'aneh H, Daraghmeh A, Qassarwi Y, Franco V, Declèves X.   +5 more
europepmc   +1 more source

Physiologically Based Biopharmaceutics Modelling-Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report. [PDF]

Pharmaceutics
McAllister M, Mistry N, Pepin X, Cole S, Tannergren C, Stamatopoulos K, Engman H, Moir A, Litou C, Gavins F, Arora S, Malamatari M, Guimarães M, Ravi A, Fotaki N, Dodd L, Holte Ø, Butler J, Dickinson PA, Popkin M, Butler A, NiOgain O, Holmstock N, Mackie C.   +23 more
europepmc   +1 more source

Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (Paracetamol)

, 2006
Literature data are reviewed on the properties of acetaminophen (paracetamol) related to the biopharmaceutics classification system (BCS). According to the current BCS criteria, acetaminophen is BCS Class III compound.
Shah, V.P., Barends, D.M., Junginger, H.E., Reppas, C., Dressman, J.B., Stavchansky, S.A., Kalantzi, L., Amidon, G.L., Midha, K.K.   +8 more
core  

Predictive Potential of BCS and Pharmacokinetic Parameters on Study Outcome: Analysis of 198 In Vivo Bioequivalence Studies. [PDF]

Eur J Drug Metab Pharmacokinet, 2023
Krajcar D, Grabnar I, Jereb R, Legen I, Opara J.   +4 more
europepmc   +1 more source

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

Pharm Res
Cheng YH, Thomas S, Tsang YC, Almeida S, Ashraf M, Fotaki N, Heimbach T, Patel N, Shah H, Jiang X, Kim MJ, Moody R, Rostami-Hodjegan A, Singh R, Zhao L, Babiskin A, Wu F.   +16 more
europepmc   +1 more source

Advances in quantitative methods and modeling for complex generic drugs and opportunities to hybridize learnings between innovator and generic drug developers. [PDF]

CPT Pharmacometrics Syst Pharmacol, 2023
Jayachandran P.
europepmc   +1 more source

Physiologically Based Biopharmaceutics Model of Apixaban for Biopharmaceutics Risk Assessment. [PDF]

Pharmaceutics
Paixão P, Petric Z, Morais JAG.
europepmc   +1 more source

Using the BCS-based biowaiver approach to exempt in vivo bioequivalence studies [PDF]

Makedonsko Farmacevtski Bilten
Ana Vavlukis Trajkovska, Meri Kantardzioska, Zlatica Bojadzieska   +2 more
doaj   +1 more source

Challenges in the Investigation of Therapeutic Equivalence of Locally Applied/Locally Acting Drugs in the Gastrointestinal Tract: The Rifaximin Case. [PDF]

Pharmaceutics
Tsakiridou G, Papanastasiou AM, Efentakis P, Angelerou MFG, Kalantzi L.   +4 more
europepmc   +1 more source