Results 231 to 240 of about 187,044 (318)

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

A Phase 1, Randomized, Open‐Label, Parallel Group Study to Evaluate the Relative Bioavailability and Safety of Subcutaneous Bepirovirsen when Delivered from a Vial or Prefilled Syringe Fitted with a Safety Syringe Device in Healthy Adult Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Bepirovirsen, an antisense oligonucleotide in development for the treatment of chronic hepatitis B virus (HBV) infection, is administered from glass vials as a subcutaneous (SC) injection by healthcare professionals (HCPs). A ready‐to‐use prefilled syringe (PFS) assembled with a safety syringe device (SSD) has been developed to make ...
Amir S. Youssef, Poonam Shah, Maxwell Hu, Helene Plein, Abhishek Roy, Ravi Sharma, Sarah Mole, Magdalena Blazejczyk, Wendy Cross, Brian Spears, Samuel Pak, Rejbinder Kaur, Robert Elston, Dickens Theodore, Marjan Hezareh, Ahmed Nader   +15 more
wiley   +1 more source

Messenger RNA vaccines as adjuncts to surgical oncology: a new era in neoplasm immunotherapy and precision medicine. [PDF]

Ann Med Surg (Lond)
Mehmood MS, Hajj F.
europepmc   +1 more source

Association of Fluconazole Pharmacodynamics with Mortality in Patients with Candidemia

, 2008
John W. Baddley, Mukesh Patel, Sujata M. Bhavnani, Stephen A. Moser, David R. Andes   +4 more
openalex   +1 more source

Effects of High‐ and Low‐Fat Meals on the Bioavailability and Pharmacokinetics of Votoplam, a HTT Gene Splicing Modifier

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Votoplam is a novel, orally bioavailable, small molecule HTT gene splicing modifier that is being developed for the treatment of Huntington's disease. This was a single dose, open‐label, two‐period, crossover food effect study that evaluated the effect of high‐ and low‐fat meals on 20 mg votoplam in healthy participants. There was a washout of
Lucy Lee, Amy‐Lee Richards, Nageswara Reddy, Brian Beers, Lee Golden, Ronald Kong   +5 more
wiley   +1 more source

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

Clinical Pharmacology &Therapeutics, EarlyView.
We present model‐informed selection of the recommended dose for expansion (RDE) of investigational oral ATR inhibitor tuvusertib, by integrating clinical pharmacokinetics (PK), pharmacodynamics (PD), and safety data from DDRiver Solid Tumors 301 trial Part A1 (NCT04170153).
Jatinder Kaur Mukker, Paul Matthias Diderichsen, Farina Hellmann, Timothy A. Yap, Ruth Plummer, Anthony W. Tolcher, Johann S. de Bono, Ioannis Gounaris, Zoltan Szucs, Astrid Zimmermann, Irina Kareva, Jayaprakasam Bolleddula, Annick Seithel‐Keuth, Giuseppe Locatelli, Marta Enderlin, Christine Hicking, Anup Zutshi, Wei Gao, Rainer Strotmann, Lisa Benincosa, Karthik Venkatakrishnan   +20 more
wiley   +1 more source

Efficacy and safety of isavuconazole for invasive fungal infections: A systematic review and meta-analysis of randomized controlled trials. [PDF]

Med Mycol
Kawasaki A, Shintani R, Takao R, Nakazawa Y, Mihara T, Ikegami S, Shimada S, Matsumoto Y, Okamoto Y, Igarashi Y, Enoki Y, Taguchi K, Matsumoto K.   +12 more
europepmc   +1 more source

Population Pharmacokinetics and Exposure–Response Analyses of Momelotinib, Its Active Metabolite (M21), and Total Active Moiety in Myelofibrosis

Clinical Pharmacology &Therapeutics, EarlyView.
Momelotinib, a Janus kinase (JAK) 1/JAK2/activin A receptor type 1 inhibitor, is approved for the treatment of myelofibrosis with anemia. These analyses characterized the population pharmacokinetics of momelotinib and its active metabolite M21 following administration of the commercial tablet formulation in patients with myelofibrosis from phase II/III
Benjamin Rich, Meenakshi Srinivasan, Yu Liu Ho, Sandra A.G. Visser, Geraldine Ferron‐Brady, Georgios Vlasakakis   +5 more
wiley   +1 more source

Breaking Barriers: Characterization of the Intradermal Lipopolysaccharide Challenge as an In Vivo Model for Controlled Induction of Vascular Leakage in Healthy Volunteers

Clinical Pharmacology &Therapeutics, EarlyView.
Vascular leakage and its associated phenomena vasodilation and endothelial activation are pathophysiological features of various diseases. Multiple drug candidates targeting these phenomena are in development, necessitating translational models to demonstrate proof‐of‐pharmacology and proof‐of‐mechanism in early‐phase clinical trials.
Marella Cornelia Elizabeth van Ruissen, Menno van Diemen, Liza Botros, Ingrid Tomljanovic, Hind Achbo, Dimitra Eleftheriou, Paul Willem Schenk, Naomi Bertine Klarenbeek, Derek William Gilroy, Manon Aleida Adriana Jansen, Matthijs Moerland   +10 more
wiley   +1 more source

PP7.10 – 00018 The effects of P-glycoprotein, breast cancer resistance protein, and CYP3A4 modulators on the pharmacokinetic and pharmacodynamic responses of the TLR7 agonist vesatolimod in people living with HIV

Robert W. Omange, Lan Zhang, Mary Beth Wire, Yaxin Zheng, Sicong Huang, R. Palaparthy, Devi SenGupta, Jeffrey J. Wallin, Corinne S de Vries, Yu Cai   +9 more
openalex   +1 more source