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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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
doaj +3 more sources
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
doaj +3 more sources
Therapeutic Equivalence of a New Preparation of Liquid Levothyroxine with Tablets in Patients with Overt Primary Hypothyroidism. [PDF]
Eur Thyroid J, 2021 Background: A new liquid levothyroxine (LT4) dissolved in glycerol and water has recently been developed by a Greek pharmaceutical company (Uni-Pharma, Athens, Greece).
Markantes GK +6 more
europepmc +2 more sources
JAMA Netw Open, 2023 Key Points Question Are biosimilars of adalimumab, etanercept, and infliximab associated with equivalent treatment compared with their reference biologic drugs for the management of rheumatoid arthritis?
Ascef BO +5 more
europepmc +2 more sources
Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial. [PDF]
Clin Pharmacol Ther, 2019 Controversy persists about bupropion XL 300 mg generic equivalence to brand product. A prospective, randomized, double‐blinded crossover in 70 adults with major depression in stable remission taking any bupropion XL 300 mg tested bioequivalence and ...
Kharasch ED +7 more
europepmc +2 more sources
Pharmaceutical "New Prior Knowledge": Twenty-First Century Assurance of Therapeutic Equivalence. [PDF]
AAPS PharmSciTech, 2019 Facilitating utility of prior knowledge to accelerate evidence-based new drug development is a focus of several communities of knowledge, such as clinical pharmacology.
Hussain AS, Gurvich VJ, Morris K.
europepmc +2 more sources
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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Testing the therapeutic equivalence of alogliptin, linagliptin, saxagliptin, sitagliptin or vildagliptin as monotherapy or in combination with metformin in patients with type 2 diabetes. [PDF]
Diabetes Ther, 2014 BackgroundIn studying the therapeutic evidence of innovative drug treatments, increasing attention is being devoted to differentiating between results that indicate no significant differences among the treatments under examination (“no proof of ...
Messori A +4 more
europepmc +2 more sources
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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