Results 21 to 30 of about 351,529 (205)

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

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

RNAi drugs: Next generation drugs? [PDF]

Chinese Science Bulletin, 2020
Gene therapy aims to apply biotechnological techniques to correct a defective gene through administrating therapeutic nucleic acids or editing a defective gene. The approaches used in gene therapy include traditional transgene, genome editing, such as CRISPR/CAS9, RNA interference (RNAi) and antisense oligonucleotides (ASOs), etc.
Bingxue Yan, Yuqian Mi, Qingwei Cui, Zhou Tong, Anoliefo Ijeoma Janefrancis, Shan Gao   +5 more
openaire   +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

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

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

A Budding Theory of Willful Patent Infringement: Orange Books, Colored Pills, and Greener Verdicts [PDF]

, 2007
The rules of engagement in the brand-name versus generic-drug war are rapidly changing. Brand-name manufacturers face increasing competition from Canadian manufacturers of generic drugs, online drug companies, and Wal-Mart® Super Centers deciding to cash
Harkins, Christopher A.
core   +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

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

Generic versus brand-name drugs used in cardiovascular diseases [PDF]

, 2016
This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines.
Boccia, Stefania, D'Andrea, Elvira, Flacco Maria, Elena, Ioannidis John, Pa, Manzoli, Lamberto, Marzuillo, Carolina, Panic, Nikola, Ricciardi, Walter, Siliquini, Roberta, Villari, Paolo   +9 more
core   +1 more source