Results 61 to 70 of about 219,082 (266)

Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects

BMC Medical Research Methodology
Background This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.
Turki A. Althunian, Bader R. Alzenaidy, Raseel A. Alroba, Ohoud A. Almadani, Fahad A. Alqahtani, Albatool A. Binajlan, Amal I. Almousa, Deema K. Alamr, Malak S. Al-Mofada, Nora Y. Alsaqer, Hessa A. Alarfaj, Abdulmohsen A. Bahlewa, Mohammed A. Alharbi, Ali M. Alhomaidan, Abdulaziz A. Alsuwyeh, Abdulmohsen A. Alsaleh   +15 more
doaj   +1 more source

Application of the Nested Enzyme‐Within‐Enterocyte (NEWE) Turnover Model for Predicting the Time Course of Pharmacodynamic Effects

CPT: Pharmacometrics & Systems Pharmacology, 2020
The gut wall consists of many biological elements, including enterocytes. Rapid turnover, a prominent feature of the enterocytes, has generally been ignored in the development of enterocyte‐targeting drugs, although it has a comparable rate to other ...
Hiroyuki Takita, Adam S. Darwich, Amais Ahmad, Amin Rostami‐Hodjegan   +3 more
doaj   +1 more source

Bile Duct Ligation Upregulates Expression and Function of L-Amino Acid Transporter 1 at Blood–Brain Barrier of Rats via Activation of Aryl Hydrocarbon Receptor by Bilirubin

Biomedicines, 2021
Liver failure is associated with increased levels of brain aromatic amino acids (AAAs), whose transport across the blood–brain barrier (BBB) is mainly mediated by L-amino acid transporter 1 (LAT1). We aimed to investigate whether liver failure induced by
Xiaoke Zheng, Hanyu Yang, Lan Qin, Siqian Wang, Lei Xie, Lu Yang, Weimin Kong, Liang Zhu, Li Liu, Xiaodong Liu   +9 more
doaj   +1 more source

If it does not help, it might hurt: Pharmacodynamics of a second IVIg course in Guillain–Barré syndrome

Annals of Clinical and Translational Neurology, EarlyView.
Abstract Objectives Intravenous immunoglobulin (IVIg) is an effective treatment for Guillain–Barré syndrome (GBS), but recovery varies between patients. This study aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of a single and a second IVIg dose (SID) in patients with GBS.
Sander J. van Tilburg, Ruth Huizinga, Krista Kuitwaard, Sebastiaan D.T. Sassen, Christa Walgaard, Pieter A. van Doorn, Bart C. Jacobs, Birgit C.P Koch   +7 more
wiley   +1 more source

Cyclosporine Absorption Following Orthotopic Liver Transplantation [PDF]

, 1986
Blood concentrations of cyclosporine were determined in adult and pediatric patients following orthotopic liver transplantation to quantitate cyclosporine blood clearance and oral absorption.
Beveridge, Burckart, Burckart, Calne, Calne, Holt, Kahan, Kennedy, Malatack, Miles, Ptachcinski, Ptachcinski, Ptachcinski, Sawchuk, Starzl, Starzl, Starzl, Venkataramanan, Venkataramanan, Venkataramanan, Wood   +20 more
core   +2 more sources

Combined Systemic Immunotherapy and Intrathecal Dexamethasone in Febrile Infection Related Epilepsy Syndrome

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Febrile infection related epilepsy syndrome (FIRES) is a rare presentation of refractory status epilepticus with immune dysregulation as a potential pathologic mechanism. Despite promising results from second‐line immunomodulators, approximately 30% remain refractory to treatment.
Kristen S. Fisher, Alexander Ankar, Jon Cokley, Eyal Muscal, James J. Riviello, Yi‐Chen Lai   +5 more
wiley   +1 more source

Phase 1, First‐In‐Human, Single‐/Multiple‐Ascending Dose Study of Iluzanebart in Healthy Volunteers

Annals of Clinical and Translational Neurology, EarlyView.
ABSTRACT Objective To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of iluzanebart, a fully human monoclonal antibody TREM2 (triggering receptor expressed on myeloid cells 2) agonist, after single‐ (SAD) and multiple‐ascending‐dose (MAD) administration.
Andreas Meier, Spyros Papapetropoulos, Andrew Marsh, Kelly Neelon, David Stiles, Ryan O'Mara, Evan A. Thackaberry, Marco Colonna, Raj Rajagovindan   +8 more
wiley   +1 more source

Incidence and risk factors of neonatal hypoglycemia after ritodrine therapy in premature labor: a retrospective cohort study

Journal of Pharmaceutical Health Care and Sciences, 2019
Background Ritodrine hydrochloride (RD), a β2-adrenergic agonist, is widely used as a tocolytic medication to suppress premature labor, but can cause neonatal hypoglycemia, a potentially severe side effect.
Shoko Shimokawa, Akiko Sakata, Yukio Suga, Kazuya Isoda, Shingo Itai, Katsuhiko Nagase, Tsutomu Shimada, Yoshimichi Sai   +7 more
doaj   +1 more source

Cross-Validation for Nonlinear Mixed Effects Models [PDF]

Journal of Pharmacokinetics and Pharmacodynamics, April 2013, 40(2): 243-252, 2013
Cross-validation is frequently used for model selection in a variety of applications. However, it is difficult to apply cross-validation to mixed effects models (including nonlinear mixed effects models or NLME models) due to the fact that cross-validation requires "out-of-sample" predictions of the outcome variable, which cannot be easily calculated ...
arxiv   +1 more source

Pharmacokinetic study of praziquantel enantiomers and its main metabolite R-trans-4-OH-PZQ in plasma, blood and dried blood spots in Opisthorchis viverrini-infected patients [PDF]

, 2016
Praziquantel (PZQ) is the treatment of choice for infections with the liver fluke Opisthorchis viverrini, a major health problem in Southeast Asia. However, pharmacokinetic (PK) studies investigating the disposition of PZQ enantiomers (R- and S-PZQ) and ...
Duthaler, Urs, Huwyler, Jörg, Keiser, Jennifer, Kovac, Jana, Meister, Isabel, Odermatt, Peter, Sayasone, Somphou, Vanobberghen, Fiona   +7 more
core   +2 more sources