Results 21 to 30 of about 107,682 (255)

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou, Andrew Babiskin, Liang Zhao   +2 more
doaj   +1 more source

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States.
Ross L. Walenga, Clare Butler, Brent A. Craven, P. Worth Longest, Raja Mohamed, Bryan Newman, Bo Olsson, Günther Hochhaus, Bing V. Li, Markham C. Luke, Liang Zhao, Andrzej Przekwas, Robert Lionberger   +12 more
doaj   +1 more source

Advances in brain-targeted delivery strategies and natural product-mediated enhancement of blood–brain barrier permeability

Journal of Nanobiotechnology
The 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, Xingyue Jin, Yuanyuan Ge, Junlin Dong, Xinyue Liu, Xiao Pei, Ping Wang, Bing Wang, Yanxu Chang, Xie-an Yu   +9 more
doaj   +1 more source

Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

EClinicalMedicine, 2021
Background: Over the past decade, U.S. FDA has approved 10 opioid analgesics in abuse-deterrent formulations (ADFs). ADFs are intended to reduce abuse of a prescription opioid through manipulation of the product to use one or more routes of abuse ...
Liang Zhao, Zhichuan Li, Lanyan Fang, Myong-Jin Kim, Srikanth C. Nallani, Chandrahas G. Sahajwalla, Silvia N. Calderon, Rigoberto A. Roca, Kairui Feng, Issam Zineh, Robert Lionberger   +10 more
doaj   +1 more source

Reciprocal control of viral infection and phosphoinositide dynamics

FEBS Letters, EarlyView.
Phosphoinositides, although scarce, regulate key cellular processes, including membrane dynamics and signaling. Viruses exploit these lipids to support their entry, replication, assembly, and egress. The central role of phosphoinositides in infection highlights phosphoinositide metabolism as a promising antiviral target.
Marie Déborah Bancilhon, Bruno Mesmin
wiley   +1 more source

A comparative analysis of the microbiome of cigars produced in the Caribbean and China

Scientific Reports
Fermentation of cigar tobacco leaves involves intense microbial activity, and hence, microorganisms have a significant impact on the quality and flavour of cigars. However, research on the correlation between microbial communities and the sensory quality
Bo Ding, Yuan Ji, Xiaojie Xu, Xiaokang Cui, Xiaoli Meng, Zhen Shen, Lihong Ren, Yinghui Guo, Sheng Xing, Shili Liu, Min Liu   +10 more
doaj   +1 more source

Key Factors for Improving Predictive Accuracy and Avoiding Overparameterization of the PBPK Absorption Model in Food Effect Studies of Weakly Basic Water-Insoluble Compounds in Immediate Release Formulations

Pharmaceutics
Background/Objectives: Physiologically based pharmacokinetic (PBPK) absorption models are instrumental for assessing drug absorption prior to clinical food effect studies, though discrepancies in predictive and actual outcomes are observed.
Miao Zhang, Shudong Zhang, Lin Wang, Zhe Zhang, Qin Hu, Dongyang Liu   +5 more
doaj   +1 more source

Microbiome−host proteostasis crosstalk—An emerging perspective on mechanisms and interventions toward healthy longevity

FEBS Letters, EarlyView.
Proteostasis and the gut microbiota play a key role in shaping host physiology. Microbiota‐derived metabolites, vitamins, and RNA modulate host proteostasis. Findings from model systems, including C. elegans, indicate microbes can either stabilize or disrupt host proteostasis.
Abhishek Anil Dubey, Maria Ermolaeva
wiley   +1 more source

Amphotericin B release rate is the link between drug status in the liposomal bilayer and toxicity

Asian Journal of Pharmaceutical Sciences, 2022
Amphotericin B (AmB) is an amphiphilic drug commonly formulated in liposomes and administered intravenously to treat systemic fungal infections. Recent studies on the liposomal drug product have shed light on the AmB aggregation status in the bilayer ...
Yuri Svirkin, Jaeweon Lee, Richard Marx, Seongkyu Yoon, Nelson Landrau, Md Abul Kaisar, Bin Qin, Jin H. Park, Khondoker Alam, Darby Kozak, Yan Wang, Xiaoming Xu, Jiwen Zheng, Benjamin Rivnay   +13 more
doaj   +1 more source

Microbiome‐blood–brain barrier interactions in aging — mechanisms and therapeutic potential

FEBS Letters, EarlyView.
Aging reshapes the gut microbiome (↓SCFA‐producing commensals; ↑pro‐inflammatory outputs), shifting circulating metabolites (↓SCFAs; ↑LPS, ↑TMAO, ↑PAA) that act at the BBB to increase nonspecific transcytosis, alter transport, and promote astrocyte reactivity, heightening brain vulnerability.
Daniel Cuervo‐Zanatta, Hari Baskar Balasubramanian, Amir Pasokh, Marietta Zille   +3 more
wiley   +1 more source