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Více informací o knize Data exclusivity for Rx-to-OTC switches in Europe

• Parametry knihy
• Anotace
• Oblíbené z jiného soudku

Anotace knihy

Prescription-free medicinal products play an important role when it comes to providing people suffering from self-diagnosable and self-treatable diseases with safe and effective treatment options.§The change of classification of medicinal products for human use from prescription to non- prescription status (commonly called Rx-to-OTC switch) is the key procedure when it comes to innovating and improving self-medication. §The purpose thereof is to provide new and perhaps better options for self-medication, but granting effectiveness as well as safety in the treatment of diseases partly not yet established as a self-treatment option.§While the development of new substances to be used as medicinal products is well standardized, the change to non-prescription status is much less defined, making decisions about how to proceed a process with several confounding factors.§This thesis discusses the legal background for a change of class of prescription products in Europe and regulatory pathways to be considered when aiming for a successful Rx-to-OTC switch. Focus is laid on data exclusivity as a means to control and improve patient behavior and thus treatment outcome. §Options for obtaining data exclusivity are analyzed via post-hoc analysis of some actual cases and proposals are set up how to generate data which reflect patients' needs and knowledge for self-medication more than data derived from prescription use, thus adding new categories of data to be acknowledged as necessary, relevant and new.

Parametry knihy

• Plný název: Data exclusivity for Rx-to-OTC switches in Europe
• Autor: Carolin Stäbler
• Jazyk: Angličtina
• Vazba: Brožovaná
• Počet stran: 208
• EAN: 9783774112599
• ISBN: 3774112592
• ID: 05290113
• Nakladatelství: Govi-Verlag
• Hmotnost: 514 g
• Rozměry: 239 × 171 × 12 mm
• Datum vydání: 18. March 2014

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