Results 41 to 50 of about 26,646 (226)
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 +6 more
wiley +1 more source
Rupture Test and Bioavailability of Oil-Soluble Vitamins [PDF]
, 2013 In lieu of an abstract, here is the article\u27s first paragraph: Bioavailability of multi-vitamins as dietary supplements has always been a concern. Dissolution studies have been successfully used to predict drug release of bioactive molecules, but with
Chablani, Lipika
core +2 more sources
Journal of NanobiotechnologyThe blood–brain barrier (BBB) represents a formidable challenge in the treatment of neurological disorders, as it restricts the passage of most therapeutic agents into the central nervous system (CNS).
Suyi Liu +9 more
doaj +1 more source
Фармакокинетика и Фармакодинамика, 2023 Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 ...
A. L. Khokhlov +4 more
doaj +1 more source
A Review of Virtual Twins in Physiologically‐Based Pharmacokinetic Modeling and Simulation
Clinical Pharmacology &Therapeutics, EarlyView.The novel application of Virtual Twins (VT) in PBPK (VT‐PBPK) presents the opportunity to advance precision dosing and accelerate the shift from one‐size‐fits‐all to targeted, individualized treatments. This review aims to: (1) critically evaluate existing research on the use of VTs in PBPK, (2) develop a conceptual definition of VT‐PBPK, (3) describe ...
Emily Mannix +4 more
wiley +1 more source
Assessing the similarity of dose response and target doses in two non-overlapping subgroups [PDF]
, 2017 We consider two problems that are attracting increasing attention in clinical dose finding studies. First, we assess the similarity of two non-linear regression models for two non-overlapping subgroups of patients over a restricted covariate space.
Bretz, Frank +4 more
core +2 more sources
CPT: 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
An Example of How to Write the Statistical Section of a Bioequivalence Study Protocol for FDA Review [PDF]
, 2007 This paper provides a detailed example of how one should write the statistical section of a bioequivalence study protocol for FDA review. Three forms of bioequivalence are covered: average bioequivalence (ABE), population bioequivalence (PBE) and ...
McCarthy, William F.
core +1 more source
Recent advances in self-targeting natural product-based nanomedicines
Journal of NanobiotechnologyNatural products, recognized for their potential in disease prevention and treatment, have been integrated with advanced nano-delivery systems to create natural product-based nanomedicines, offering innovative approaches for various diseases.
Haifan Liu +11 more
doaj +1 more source
Pharmacology Research & Perspectives, 2021 The COVID‐19 pandemic has forced clinical studies to accommodate imposed limitations. In this study, the bioequivalence part could not be conducted as planned.
Dénes Csonka +6 more
doaj +1 more source