Results 21 to 30 of about 80,706 (309)

Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products

Journal of Pharmacy & Pharmaceutical Sciences, 2017
The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January ...
Paramjeet Kaur, Xiaojian Jiang, Ethan Stier   +2 more
doaj   +1 more source

Virtual screening FDA approved drugs against multiple targets of SARS‐CoV‐2

Clinical and Translational Science, 2021
The outbreak of the novel coronavirus severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2), the causative agent of coronavirus disease 2019 (COVID‐19) respiratory disease, led to a global pandemic with high morbidity and mortality.
Hualou Liang, Liang Zhao, Xiajing Gong, Meng Hu, Hongbin Wang   +4 more
doaj   +1 more source

Prescribing Behavior of General Practitioners for Generic Drugs [PDF]

International Journal of Environmental Research and Public Health, 2020
The factors influencing General Practitioners’ (GPs) prescribing behavior are diverse in terms of health care policies and regulations, GPs’ education and experience, demographic trends and disease profiles. Thus, it can be useful to analyze the specific local patterns, as they affect the quality of healthcare and the stability of the healthcare market.
Tuncay, Berna, Pagano, Sergio, De Santis, Mario, Cavallo, Pierpaolo   +3 more
openaire   +6 more sources

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

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

MOESM1 of Representative sample survey on factors determining the Czech physicians’ awareness of generic drugs and substitution

, 2019
Additional file 1. Questionnaire survey. Specific items included in the questionnaire concerning statements related to brand name drugs, generic drugs and generic substitution, previous experience with drug-related problems of generic drugs and generic ...
K. Mala-Ladova (7593329), J. Maly (7593314), E. Zimcikova (7593317), J. Kostriba (7593326), A. Kubena (7593323), J. Babica (7593320)   +5 more
core   +1 more source

Prescribing patterns of cardiovascular drugs in cardiology outpatient department in a tertiary care hospital in Western Odisha

, 2020
Background: Cardiovascular morbidity plays a villainous role globally as well as countries like India. Additionally, irrational prescription incurs greater damage to health and wellbeing.
Roy, Ayan, Patel, Nayan Kumar
core   +2 more sources

Non-equivalence of antibiotic generic drugs and risk for intensive care patients

, 2013
Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic ...
Reshetnykov, Mykhaylo, Rangoonwala, Ramzan, Ghanaati, Shahram Michael, Kirkpatrick, Charles James, Barbeck, Mike   +4 more
core   +1 more source