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Anotace knihy

The term "ATMs" is understood to refer to both advanced therapy medicinal products that have been granted a marketing authorization and advanced therapy medicinal products that are the subject of clinical trials or are used as a reference in a clinical trial (investigational advanced therapy medicinal product). This guide specifies the GMP requirements that must govern the manufacture of ATMPs that have been granted a marketing authorization and ATMPs used in a clinical trial context. This guide does not apply to medicinal products other than ATMPs. However, the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/c4 and Article 63(1) of Regulation (EU) No 536/2014 do not apply to ATMPs unless specifically referred to in these guidelines. If specific provisions only concern advanced therapy medicinal products that have been granted a marketing authorization, the term used is "authorized ATMPs".

Parametry knihy

Zařazení knihy Knihy v němčině Naturwissenschaften, Medizin, Informatik, Technik Medizin Ganzheitsmedizin

• Plný název: The Genomic Complex
• Autor: Abdoul Hamid Derra
• Jazyk: Angličtina
• Vazba: Brožovaná
• Počet stran: 540
• EAN: 9783330511231
• ISBN: 3330511230
• ID: 48357966
• Nakladatelství: Our Knowledge Publishing
• Hmotnost: 822 g
• Rozměry: 220 × 150 × 33 mm
• Datum vydání: 15. April 2025

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