Results 11 to 20 of about 26,646 (226)
Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products [PDF]
, 2005 Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind\u27s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes
Wasson, Andrew
core +3 more sources
Application in silico Modeling Simulation in Bioequivalence Studies: A Review
Journal of Food and Pharmaceutical Sciences, 2023 Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies ...
Sekar Ayu Pawestri
doaj +1 more source
Drugs in R&D, 2023 Background and Objectives Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development.
Dejan Krajcar +4 more
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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 +9 more
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Data in Brief, 2016 The efavirenz pharmacokinetic raw data presented in this article was obtained in an average bioequivalence study between a local brand and Stocrin (Merck Sharp & Dohme, purchased from Australia, batch H009175, expiration date November 2013).
Manuel Ibarra +4 more
doaj +1 more source
New Bioequivalence Studies : Individual Bioequivalence and Population Bioequivalence
YAKUGAKU ZASSHI, 2000 The bioequivalence study which is currently conducted in different countries is the so-called average bioequivalence approach; this approach has been indicated to be insufficient for assessing switchability between two formulations (i.e., from the reference formulation to the test formulation).
K, Nakai, M, Fujita, H, Ogata
openaire +3 more sources
Relevant Issues of Planning Bioequivalence Studies of Drugs with a Narrow Therapeutic Range
Регуляторные исследования и экспертиза лекарственных средств, 2020 In order to be registered, generic drugs with a narrow therapeutic range have to undergo bioequivalence or therapeutic equivalence studies. In most cases, comparative pharmacokinetic studies and demonstration of bioequivalence between the test and the ...
D. P. Romodanovsky
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CPT: Pharmacometrics & Systems Pharmacology, 2022 Among the current approaches for the analysis of bioequivalence, the average bioequivalence (ABE) is limited only to the mean bioavailability, whereas the population bioequivalence (PBE) criterion aggregates both mean and variance in a general comparison
Sara Soufsaf, Fahima Nekka, Jun Li
doaj +1 more source
Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines [PDF]
, 2016 The aim of this study was to evaluate the bioequivalence of two commercial long-acting formulations based on oxytetracycline (OTC) hydrochloride between the reference formulation (Terramycin LA, Pfizer) and a test formulation (Cyamicin LA, Fort Dodge ...
Fernandez Lastra, Cecilia +7 more
core +4 more sources
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
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