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EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets.
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) Directives. Directive 65/65/EEC1, requires prior approval for marketing ...
(Reuters) - The European Medicines Agency's (EMA) safety committee on Friday recommended changes to product information for all medicines that contain the ingredient pseudoephedrine to address ...
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
The Falsified Medicines Directive is a legal framework introduced by the European Commission, to improve the protection of public health within the European Union.The directive applies since 2 January 2013.
Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).
Kendra Wilkinson is reacting to harsh comments she has recently received about her body on social media. On Jan. 12, the mom of two penned a lengthy response on Instagram to critics who have left ...