Results 111 to 120 of about 826 (178)

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

Clinical Pharmacology &Therapeutics, Volume 120, Issue 1, Page 43-54, July 2026.
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

Engineering Bone‐Targeted LNP Delivery of Anti‐Sclerostin Antibody mRNA for the Treatment of Osteoporosis

Journal of Biomedical Materials Research Part A, Volume 114, Issue 7, July 2026.
ABSTRACT Messenger RNA (mRNA) therapy represents a transformative platform in regenerative medicine, but its application to skeletal disorders remains limited by the pronounced hepatic tropism of conventional lipid nanoparticle (LNP) delivery systems.
Pengcheng Ren, Diaodiao Wang, Wenqiang Sun, Danning Li, Sidong Yang, Shudong Zhang, Yiquan Zhang, Yubo Liu, Peng Hu, Jiaxin Li, Qi Yao   +10 more
wiley   +1 more source

Butorphanol Pharmacokinetics Across Species: Meta‐Analysis Integrating Allometric Scaling and Minimal Physiologically Based Pharmacokinetic Modeling

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 7, July 2026.
mPBPK Allometric Meta‐Analysis (MAMA) of Butorphanol Across 13 Species. ABSTRACT Butorphanol, an opioid agonist–antagonist used in human and veterinary medicine, lacks systematic interspecies comparisons. Butorphanol pharmacokinetics (PK) was assessed across species using a minimal physiologically based PK (mPBPK) model and allometric scaling, termed ...
Ahmed M. Saeed, William J. Jusko
wiley   +1 more source

From the Proteome to Therapeutics: A Multi‐Database Approach to Drug Discovery in Periodontitis—An Exploratory Pilot Study

Journal of Clinical Periodontology, Volume 53, Issue 7, Page 990-1004, July 2026.
ABSTRACT Introduction This explanatory pilot study presents a workflow to identify approved drugs, which could be repurposed for periodontitis therapy using salivary proteomics combined with drug‐target database screening. Methods Proteomic analyses of saliva using LC–MS/MS were conducted in two independent settings: a cohort (sub‐study I, N = 187) and
Taisir Bozo, Annette Murr, Birte Holtfreter, Sebastian‐Edgar Baumeister, Peter Meisel, Uwe Völker, Werner Weitschies, Henry Völzke, Philipp Kanzow, Elke Hammer, Manuela Gesell Salazar, Thomas Kocher   +11 more
wiley   +1 more source

Model-based analysis of biopharmaceutic experiments to improve mechanistic oral absorption modeling : an integrated in vitro in vivo extrapolation perspective using Ketoconazole as a model drug

, 2017
Mechanistic modeling of in vitro data generated from metabolic enzyme systems (viz., liver microsomes, hepatocytes, rCYP enzymes, etc.) facilitates in vitro–in vivo extrapolation (IVIV_E) of metabolic clearance which plays a key role in the successful ...
Kostewicz, Edmund S., Edmund S. Kostewicz, David B. Turner, Patel, Nikunjkumar, Ruff, Aaron, Jamei, Masoud, Turner, David B., Nikunjkumar Patel, Shriram M. Pathak, Masoud Jamei, Aaron Ruff, Pathak, Shriram M.   +11 more
core   +1 more source

Physiologically Based Biopharmaceutics Modeling (PBBM) to Evaluate the Biopredictive Power of Dissolution Methods for Rivaroxaban Tablets

The aim of this study was to use the physiologically based biopharmaceutics modeling (PBBM) strategy to evaluate the biopredictive power of different dissolution test conditions for immediate release tablets containing 20 mg of rivaroxaban. The model was developed and validated with literature data and used to predict plasma concentration-time curves ...
Eduardo Nabais de Carvalho Lauro, Bruna Wenyi Chuang Jou, Humberto Gomes Ferraz, Michele Georges Issa, Marcelo Dutra Duque   +4 more
openaire   +1 more source

The Development of an Age-Appropriate Fixed Dose Combination for Tuberculosis Using Physiologically-Based Pharmacokinetic Modeling (PBBM) and Risk Assessment

Background/Objectives: The combination of isoniazid (INH) and rifampicin (RIF) is indicated for the treatment maintenance phase of tuberculosis (TB) in adults and children.
Xavier J. H. Pepin, Sandra Suarez Sharp, Livia Deris Prado, Juliana Johansson Soares Medeiros   +3 more
core   +1 more source

Physiologically Based Pharmacokinetic Modeling for Predicting Drug Levels After Bariatric Surgery: Vardenafil Exposure Before vs. After Gastric Sleeve/Bypass

Bariatric surgery involves major changes in the anatomy and physiology of the gastrointestinal tract, which may alter oral drug bioavailability and efficacy. Phosphodiesterase-5 inhibitor (PDE5i) drugs are the first-line treatment of erectile dysfunction,
Daniel Porat, Dukhno, Oleg, Arik Dahan, Dahan, Arik, Sandra Cvijić, Oleg Dukhno, Porat, Daniel, Cvijić, Sandra   +7 more
core   +1 more source

Biowaiver monographs for immediate-release solid oral dosage forms:Lemborexant

Lemborexant is a dual orexin receptor antagonist assigned to class II of the Biopharmaceutics Classification System (BCS). Thus, the ICH M9 Guideline excludes immediate-release (IR) solid oral dosage forms containing lemborexant from BCS-based biowaivers,
Langguth, Peter, Beran, Kristian, Charoo, Naseem, Polli, James E., Shah, Vinod P., Holm, René; id_orcid, Parr, Alan, Cristofoletti, Rodrigo, Abrahamsson, Bertil, Mehta, Mehul, Kambayashi, Atsushi, Dressman, Jennifer   +11 more
core   +1 more source

Drug absorption in the lungs : studies in the isolated perfused rat lung model combined with physiologically based biopharmaceutics modelling

, 2021
Pulmonary delivery of drugs is the preferred route of administration for treatment of local lung diseases like asthma and chronic obstructive pulmonary disease. Recently, there has also been increased interest in systemic delivery of drugs via the lungs to avoid problems with low and/or variable gastrointestinal absorption, and as a needle-free ...
openaire   +1 more source