Results 11 to 20 of about 1,553,128 (257)
Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? : findings from across Europe and their implications [PDF]
, 2014 Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments.
Barbui, Corrado +12 more
core +5 more sources
Potential to enhance the prescribing of generic drugs in patients with mental health problems in Austria; implications for the future [PDF]
, 2013 Scrutiny over pharmaceutical expenditure is increasing leading to multiple reforms. This includes Austria with measures to lower generic prices and enhance their utilization.
Barbui, Corrado +8 more
core +3 more sources
Non-equivalence of antibiotic generic drugs and risk for intensive care patients [PDF]
, 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 +4 more
core +1 more source
Frontiers in Research Metrics and Analytics, 2021 Towards the objectives of the UnitedStates Food and Drug Administration (FDA) generic drug science and research program, it is of vital importance in developing product-specific guidances (PSGs) with recommendations that can facilitate and guide generic ...
Yiwen Shi +5 more
doaj +1 more source
CPT: Pharmacometrics & Systems Pharmacology, 2023 This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day 2 of the workshop titled “Regulatory
Abdullah Al Shoyaib +10 more
doaj +1 more source
CPT: Pharmacometrics & Systems Pharmacology, 2023 For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tissues at the ...
Ming‐Liang Tan +8 more
doaj +1 more source
CPT: Pharmacometrics & Systems Pharmacology, 2023 On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence ...
Andrew Babiskin +12 more
doaj +1 more source
Pharmaceutics, 2023 One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and ...
Ping Ren +8 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 +4 more
doaj +1 more source
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 +2 more
doaj +1 more source