The “Square Box”: Therapeutic Equivalence as a Foundation of the WHO Model List of Essential Medicines [PDF]
Frontiers in Pharmacology, 2020 Every two years, the World Health Organization (WHO) updates its Model List of Essential Medicines, intended as a guide for countries to adopt or adapt in accordance with local priorities and treatment guidelines, for the development of national ...
Bernadette Cappello +4 more
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Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study [PDF]
Neurology International, 2022 The brand interchangeability of antiepileptic drugs (AEDs) is a topic of debate, especially regarding their therapeutic equivalence. This study evaluates the efficacy and tolerability of generic levetiracetam compared to the brand-name equivalent in a ...
Jannapas Tharavichitkun +3 more
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Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision [PDF]
Frontiers in Medicine, 2020 Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is
Rogério Sá Gaspar +13 more
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Generic drugs: benefit/risk ratio
Неврология, нейропсихиатрия, психосоматика, 2021 The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice.
E. A. Ushkalova +2 more
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Comparison of Efficacy and Safety of Lupin’s Pegfilgrastim with Neulastim® as an Adjunct to Chemotherapy in Patients with Non Myeloid Malignancies: A Randomised Phase III Clinical Study [PDF]
Journal of Clinical and Diagnostic Research, 2022 Introduction: Pegfilgrastim is indicated in patients receiving myelosuppressive anticancer drugs to reduce the Duration of Severe Neutropenia (DSN) and incidence of Febrile Neutropenia (FN).
Minish Jain +6 more
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Dissolution test for oral suspension: an overview about use and importance
Brazilian Journal of Pharmaceutical Sciences, 2022 This work aims to ascertain the comprehensiveness of dissolution tests for oral suspensions registered in Brazil and the USA. After consulting literature since 1994, a paucity of information about dissolution methods for suspensions was detected.
Thaís dos Santos Paulino Soares +3 more
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Determination of therapeutic equivalence of generic products of gentamicin in the neutropenic mouse thigh infection model. [PDF]
PLoS ONE, 2010 BackgroundDrug regulatory agencies (DRA) support prescription of generic products of intravenous antibiotics assuming therapeutic equivalence from pharmaceutical equivalence.
Andres F Zuluaga +4 more
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Dried blood spot: Utilizing dry blood for pharmacokinetic investigations - an old method with great future for therapeutic drug monitoring [PDF]
Vojnosanitetski Pregled, 2018 nema
Goločorbin-Kon Svetlana +4 more
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Assessment of the Feasibility of Therapeutic Equivalence Studies
Регуляторные исследования и экспертиза лекарственных средств, 2019 The introduction of the «therapeutic equivalence» concept into the Russian legislation is critical for evaluation of medicines interchangeability and for recognising them as generics.
D. V. Goryachev, N. E. Uvarova
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ECONOMIC REASONS FOR GENERIC CHOICE
Рациональная фармакотерапия в кардиологии, 2016 Many generic medicines appear in the pharmaceutical market now. However, they are not always completely comparable with original drugs on efficacy and safety. In this article pharmacoeconomical estimation of some generics and original drugs was performed
N. P. Kutishenko +3 more
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