Review of medicine registration system in Tanzania [PDF]
, 2019 Philosophiae Doctor - PhDRegistration of medicines is an essential function of the national medicine regulatory system of any country. Since the start of the medicine registration system in Tanzania in early 2000s, no systematic review has been carried
KISOMA, SUNDAY
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Frontiers in Pharmacology, 2022 Although rituximab is widely used off-label for complex pediatric diseases, safety reports are limited. We aimed to report evidence of its use in clinical practice, to describe the incidence of adverse drug reactions (ADR) to rituximab biosimilar Novex ...
Natalia Riva +20 more
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Pharmaceutical patenting trends on drugs and lifestyle diseases: an analysis of Indian and global status [PDF]
, 2017 The Indian pharmaceutical sector is large and has the potential of a global leader for low-priced high-quality drugs. The new patent regulations had a strong impact on the drug industry in India.
Chakraborty, Kajal +2 more
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Ars PharmaceuticaRESUMEN Objetivo: Determinar los aspectos esenciales de la reglamentación de Costa Rica referente al registro sanitario de biosimilares y compararlos con la información brindada en los dosieres de laboratorios fabricantes de heparina y enoxaparina ...
Rebeca Álvarez Brenes +3 more
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Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries
Frontiers in Pharmacology, 2017 Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries ...
Paweł Kawalec +11 more
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Recombinant Human Insulin in Global Diabetes Management – Focus on Clinical Efficacy [PDF]
, 2017 Biosynthetic human insulin and insulin analogues are the mainstay of insulin therapy for both type 1 and type 2 diabetes although access to human insulin at affordable prices remains a global issue.
Landgraf, Wolfgang +3 more
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Validation of a Size-Exclusion Chromatography Method for Bevacizumab Quantitation in Pharmaceutical Preparations: Application in a Biosimilar Study [PDF]
Separations, 2019 In May 2019, the Food and Drug Administration (FDA) proposed a quality range (QR) method for the comparative analytical assessment in biosimilar studies. In this process, several reference product lots are necessary, selected from a wide period of manufacturing dates with different shelf lives, to calculate the total variability expressed as the ...
Oliva Martín, Alexis Manuel +1 more
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Long-Acting Opioid Analgesics for Acute Pain: Pharmacokinetic Evidence Reviewed
Veterinary Sciences, 2023 Long-acting injectable (LAI) opioid formulations mitigate the harm profiles and management challenges associated with providing effective analgesia for animals. A single dose of a long-acting opioid analgesic can provide up to 72 h of clinically relevant
Betty M. Tyler, Michael Guarnieri
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The choice of gadolinium-based contrast agents: a radiologist’s responsibility between pharmaceutical equivalence and bioethical issues [PDF]
, 2017 Contrast Agents (CA) are among the most commonly prescribed drugs worldwide, and are used, with a variety of techniques, to increase and intensify the differences between body tissues and to help radiologist make diagnoses in a fast and precise way.
Cartocci, Gaia +5 more
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Pharmaceutical advice by phone enhances use of infliximab biosimilars
, 2018 25.
van Eijk, SC, Arndt, LK, Neitemeier, S
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