Results 101 to 110 of about 2,897 (211)

Tipifarnib physiologically‐based pharmacokinetic modeling to assess drug–drug interaction, organ impairment, and biopharmaceutics in healthy subjects and cancer patients

CPT: Pharmacometrics & Systems Pharmacology
A physiologically‐based pharmacokinetic (PBPK) model for tipifarnib, which included mechanistic absorption, was built and verified by integrating in vitro data and several clinical data in healthy subjects and cancer patients.
Noriko Okudaira, Howard Burt, Amitava Mitra   +2 more
doaj   +1 more source

Mechanistic Studies of Drug Dissolution Testing : Implications of solid phase properties and in vivo prognostic media [PDF]

, 2010
Drug absorption after oral administration requires that the drug first dissolves into gastro-intestinal tract liquids. In vivo dissolution of a drug is affected by physiological and drug-related physicochemical factors.
Lehto, Paula
core  

Mathematical model of blood and interstitial flow and lymph production in the liver. [PDF]

, 2013
We present a mathematical model of blood and interstitial flow in the liver. The liver is treated as a lattice of hexagonal \u2018classic\u2019 lobules, which are assumed to be long enough that end effects may be neglected and a two-dimensional problem ...
A Plaats Van Der, AC Straub, AD Burt, B Vollmar, C Debbaut, Chong Hang Ho, CM Quick, CV Greenway, D Negrini, GA Laine, H Boxenbaum, HA Wynne, HF Teutsch, HP Rani, Jennifer H. Siggers, JR Elk, Kritsada Leungchavaphongse, P Kotiluoto, RE Wells, RH Stewart, Rodolfo Repetto, T Ricken   +21 more
core   +1 more source

Justification of widened dissolution specifications of an extended-release product using physiologically based biopharmaceutics modeling

Xenobiotica
Drug products meeting the dissolution specifications is crucial in order to ensure consistent clinical performance. However, in certain cases, wider dissolution specifications may be required based on product behaviour. While the justification of such wider specifications may be challenging from a regulatory context, approaches such as physiological ...
Adithya Karthik, Bhattiprolu, Sivacharan, Kollipara, Rajkumar, Boddu, Tausif, Ahmed   +3 more
openaire   +2 more sources

Advances in Human Mass Balance Studies: An IQ Consortium Perspective on Current Practices and Emerging Trends

Clinical Pharmacology &Therapeutics, EarlyView.
Human radiolabeled mass balance studies are crucial for comprehensively characterizing the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs, providing essential data for drug development, regulatory evaluation, and product labeling.
Jason Boer, Ellen Cannady, Filip Cuyckens, Ulrike Glaenzel, Camille Granvil, Felix Huth, Alexander D. James, Wenying Li, Céline Veau, Graeme Young, Qin Yue, Gregory S. Walker, Upendra A. Argikar, Jonathan N. Bauman, Cathy Cantalloube, Yu‐Luan Chen, Ping Kang, Patricia Moliner, Mette L. Pedersen, Isabel Piel, Simone Schadt, Hanno Schieferstein, Julia Suchomel, Shuai Wang, S. Cyrus Khojasteh   +24 more
wiley   +1 more source

Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products – a PEARRL review. [PDF]

, 2019
Objectives: In this review, the current biopharmaceutical approaches for evaluation of oral formulation performance in paediatrics are discussed. Key findings: The paediatric gastrointestinal (GI) tract undergoes numerous morphological and physiological ...
Abdel-Rahman, Abrahamse, Abrams, Akram, Amidon, Anderson, Andersson, Armand, Bai, Barbero, Barrett, Batchelor, Batchelor, Batchelor, Batchelor, Batchelor, Batchelor, Batchelor, Batchelor, Bellisle, Bergman, Billeaud, Bjorkman, Boateng, Boehm, Bonner, Borrmann, Bourlieu, Bouzom, Bowles, Brendan T. Griffin, Brouwer, Brouwers, Bruyne, Butte, Butte, Calvier, Cassilly, Cattaneo, Cavell, Cavell, Centers for Disease Control and Prevention (CDC), Chew, Christos Reppas, Clarysse, Colome, Crawford, Cristofoletti, Cummins, Cummins, De Guchtenaere, De Koning, Dewey, Dewey, Dewey, Di Maio, DiMaggio, Dohil, Dresser, Dressman, Dressman, Driessche, Dunne, Edginton, Edginton, Edginton, Elburg, Elder, Elmorsi, European Food Safety Authority (EFSA), European Food Safety Authority (EFSA), European Food Safety Authority (EFSA), European Food Safety Authority (EFSA), European Food Safety Authority (EFSA), European Parliament, Ewer, Fallingborg, Fleisher, Food and Drug Administration (FDA), Fredrikzon, Fuchs, Gandhi, Gharpure, Gidding, Gidrewicz, Ginsburg, Ginsburg, Glasgow, Hardoff, Harries, Harrison, Hauser, Hauser, Havenaar, Heinig, Henry, Hens, Heyman, Horodynski, Jamei, Jann, Jarvenpaa, Jennifer B. Dressman, Johnson, Jones, Jones, Jong, Kakuda, Kalantzi, Kamstrup, Karim, Karkossa, Kaye, Keikha, Kelly, Kelly, Kerr, Kersten, Khalil, Klein, Klitgaard, Knorr, Kohlmann, Kostewicz, Ku, Ku, Kuepfer, Lancaster, Lange, Lennernäs, Litman, Lonnerholm, Lu, Lukacova, Maekawa, Maharaj, Maharaj, Maharaj, Maharaj, Mahmood, Mahmood, Malik, Manchikanti, Manrique, Maria Vertzoni, Mariana Guimarães, Marina Statelova, Martir, Mason, Mccracken, Mclean, Meakin, Mencarelli, Merchant, Metheny, Meyer, Meyers, Michaelsen, Michaelsen, Miller, Mistry, Moira Symilllides, Mooij, Mooij, Mooij, Mudie, Neville, Nicolas, Nicolson, Nikoletta Fotaki, Noimark, Notterman, Omari, Pedersen, Penna, Prasad, Preis, Purohit, Quigley, Quijano Ruiz, Rasool, René Holm, Riccardi, Riezzo, Robinson, Roman, Rune, Sachdev, Sadler, Salem, Salunke, Samant, Sandhar, Schiess, Schmidt, Schreiner, Schwartz, Schwartz, Sharma, Shawahna, Siegel, Signer, Sips, Sofianou-Katsoulis, Sondheimer, Splinter, Splinter, Splinter, Splinter, Staelens, Stampfuss, Stevens, Stratiki, Strickley, Thatrimontrichai, The International Commission on Radiological Protection, Toothaker, Tsamandouras, Tuleu, Turner, U.S. Department of Agriculture (USDA), U.S. Department of Agriculture, U.S. Department of Health and Human Services, Upton, Verbraecken, Villiger, Weaver, Westhus, Wolman, World Health Organization (WHO), World Health Organization (WHO), World Health Organization (WHO), World Health Organization (WHO), Yu, Zhuang   +233 more
core   +1 more source

Is a Clinical Trial With a Non‐Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK

Clinical Pharmacology &Therapeutics, EarlyView.
Although physiologically based pharmacokinetic (PBPK) modeling is increasingly being used to support oral drug formulation bridging, the acceptance by regulatory agencies is low. One of the primary concerns is the absence of clinical pharmacokinetic (PK) data from a non‐bioequivalent (non‐BE) batch during model validation.
Jin Dong, Andrea Moir, Xavier Pepin, Elizabeth Lowe, Sandy Hopkins, Weifeng Tang, Diansong Zhou   +6 more
wiley   +1 more source

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook

Pharmaceuticals
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product. However, bioequivalence studies represent significant complexities due to the interplay of multiple factors related to ...
Sivacharan Kollipara, Frederico Severino Martins, Rebeka Jereb, Dejan Krajcar, Tausif Ahmed   +4 more
doaj   +1 more source

Identification of novel cell-impermeant fluorescent substrates for testing the function and drug interaction of Organic Anion-Transporting Polypeptides, OATP1B1/1B3 and 2B1. [PDF]

, 2018
Organic Anion-Transporting Polypeptides are multispecific membrane proteins that regulate the passage of crucial endobiotics and drugs across pharmacological barriers. OATP1B1 and OATP1B3 have been described to play a major role in the hepatic uptake of
Bakos, Éva, Kucsma, Nóra, Német, Orsolya, Patik, Izabel, Szakács, Gergely, Szepesi, Áron, Székely, Virág, Várady, György, Özvegy-Laczka, Csilla   +8 more
core   +2 more sources

Autophagy Plays a Suppressive Role in Bladder Tumor Formation in an Orthotopic Mouse Model and Bladder Cancer Patient Specimens

The Kaohsiung Journal of Medical Sciences, EarlyView.
ABSTRACT Autophagy plays either a suppressing or promoting role during tumor development. Clarifying the role of autophagy in bladder tumorigenesis both in vitro and in vivo is crucial for developing novel therapeutic strategies through manipulating autophagy activity.
Wan‐Ting Kuo, Chin‐Chen Pan, Yi‐Wen Liu, Nan‐Haw Chow, Hong‐Lin Cheng, Shan‐Ying Wu, Sheng‐Hui Lan, Chih‐Peng Chang, Hsiao‐Sheng Liu   +8 more
wiley   +1 more source