Results 21 to 30 of about 279,027 (307)

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

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

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

CPT: Pharmacometrics & Systems Pharmacology, 2023
On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence ...
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao   +17 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

The implications of WTO accession on the pharmaceutical industry in China [PDF]

, 2002
Given the limited capabilities of R&D and global distribution channels, and the virtual non-existence of patented drugs, the Chinese pharmaceutical industry has little chance to enter the global market of Western prescription drugs and compete with the ...
Yeung, Godfrey
core   +1 more source

Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

CPT: Pharmacometrics & Systems Pharmacology, 2022
Physiologically‐based pharmacokinetic models combine knowledge about physiology, drug product properties, such as physicochemical parameters, absorption, distribution, metabolism, excretion characteristics, formulation attributes, and trial design or ...
Nikunjkumar Patel, James F. Clarke, Farzaneh Salem, Tariq Abdulla, Frederico Martins, Sumit Arora, Eleftheria Tsakalozou, Arran Hodgkinson, Omid Arjmandi‐Tash, Sinziana Cristea, Priyanka Ghosh, Khondoker Alam, Sam G. Raney, Masoud Jamei, Sebastian Polak   +14 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

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

Mechanistic modeling of drug products applied to the skin: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
The development of a generic drug product involves demonstrating that there is no significant difference in the rate and extent to which the active ingredient becomes available at the site of action, relative to the reference listed drug product.
Eleftheria Tsakalozou, Khondoker Alam, Priyanka Ghosh, Jessica Spires, Sebastian Polak, Lanyan Fang, Srinivasa Sammeta, Ping Zhao, Sumit Arora, Sam G. Raney   +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