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EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines.
It was proposed in direct response to several problems in the sterility of large volume parenteral market. The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.
Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products.
The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC. In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed responsible person ( RP ) or authorized person ...
In a mouse study, researchers found that zolpidem (Ambien), a common sleep aid, could prevent the brain from effectively clearing up 'waste', though it remains unclear whether this could affect ...
The weight loss drug Zepbound, generically known as tirzepatide, is also now an approved medication to treat obstructive sleep apnea, per a Food and Drug Administration Dec. 20 press release.. The ...
RDS Delivery Service president and CEO Larry Zogby claimed congestion pricing will cost his business, run out of Long Island City in Queens to all New York boroughs, more than a million dollars ...
The hallucinogenic effect of 2C-B-FLY is mediated by its partial agonistic activity at the 5-HT 2A serotonin receptor, but also has a high binding affinity for the 5-HT 1D, 5-HT 1E, 5-HT 1A, 5-HT 2B and 5-HT 2C receptors. Researchers suspect that 2C-B-FLY may have a MAOI action, making it dangerous to mix it with drugs like MDMA or Tramadol. [23]