Results 61 to 70 of about 4,403,980 (152)

Physiologically Based Pharmacokinetic Modeling to Assess Transporter‐Mediated Drug–Drug Interactions in Support of Labeling Recommendations for Zavegepant Nasal Spray

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Zavegepant nasal spray, a calcitonin gene‐related peptide receptor antagonist indicated for acute treatment of migraine with or without aura in adults, is a substrate for organic anion transporting polypeptide 1B3 (OATP1B3), Na+/taurocholate cotransporting polypeptide (NTCP), P‐glycoprotein (P‐gp), and cytochrome P450 3A4 (CYP3A4).
Alice Ke   +8 more
wiley   +1 more source

From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley   +1 more source

Drug Bioequivalence [PDF]

open access: yes, 1974
Report of the findings from a panel of the Office of Technology Assessment (OTA) regarding drug bioequivalence therapies. According to the report, the purpose of the Drug Bioequivalence Study Panel "was to examine the relationships between the chemical ...
United States. Congress. Office of Technology Assessment. Drug Bioequivalence Study Panel.
core  

Intranasal diamorphine population pharmacokinetics modeling and simulation in pediatric breakthrough pain

open access: yesCPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 435-447, March 2025.
Abstract Intranasal diamorphine (IND), approved for managing breakthrough pain in the UK, has been identified as an acceptable alternative offering effective, expedient, and less traumatic analgesia for children. However, the current dose regimen in pediatric populations relies on clinical expertise while the pharmacokinetics properties are poorly ...
Lianjin Cai   +6 more
wiley   +1 more source

A Comparison of Pharmacokinetics of two Tablet Formulations Containing Artemether / Lumefantrine – Quality Criteria for Malaria Treatment Assurance [PDF]

open access: yes, 2012
\ud Treatment of non-severe malaria remains a challenge to endemic areas including Tanzania. Since November 2006, Coartem® an artemisinin based combination therapy (ACT) containing artemether-lumefantrine (ALu), replaced sulphadoxine/pyrimethamine (SP ...
Alphonce, Ignace
core  

Bioequivalence Study of Two Formulations Containing Lurasidone 80 mg Tablets in Healthy Colombian Volunteers

open access: yes, 2016
4 páginasThis is a pharmacokinetic study of two formulations containing Lurasidone 80 mg, with the aim to compare the Bioavailability between the Test product (Lurasidone made by Laboratorios Lafrancol S.A, Colombia) and the Reference product (Latuda ...
Vargas M., Villarraga EA
core   +1 more source

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

open access: yesCPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai   +10 more
wiley   +1 more source

2021 International Conference on Virtual Rehabilitation Proceedings

open access: yes, 2021
Temple University. College of Public HealthInternational Conference on Virtual Rehabilitation 2021 is the 13th edition of the conference series, which is now the official conference of the International Society for Virtual Rehabilitation.
Kukshinov|   +6 more
core   +1 more source

A Simulation‐Based Assessment of Dosage Regimen Appropriateness for Multiple Myeloma Medicines Reflecting Demographic and Ethnic Differences

open access: yesClinical and Translational Science, Volume 19, Issue 8, August 2026.
ABSTRACT Bridging studies are often waived for orphan diseases such as multiple myeloma (MM) due to challenges in conducting clinical trials in small and heterogeneous populations. However, demographic and regional differences between trial participants and Asian populations may influence drug exposure and response.
Minji Kang   +4 more
wiley   +1 more source

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