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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
List of common dips; Paste – Food paste is a semi-liquid colloidal suspension, emulsion, or aggregation used in food preparation or eaten directly as a spread. [23] Pastes are often highly spicy or aromatic. List of food pastes; Spread – Foods that are literally spread, generally with a knife, onto bread, crackers, or other food products ...
Medical foods are regulated by the US Food and Drug Administration under the Food Drug and Cosmetic Act regulations. 21 CFR 101.9(j) (8). [1]The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary ...
Epileptic Disorders is a peer-reviewed medical journal focusing on quality scientific and educational content related to all aspects of epilepsy including its diagnosis, natural history, and management. The current editor-in-chief is Sandor Beniczky and it is published by John Libbey Eurotext.
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 ).
Syndromes are characterized into 4 groups based on epilepsy type: [1] a. Generalized onset epilepsy syndromes. These epilepsy syndromes have only generalized-onset seizures and include both the idiopathic generalized epilepsies (specifically childhood absence epilepsy, juvenile absence epilepsy, juvenile myoclonic epilepsy and epilepsy with generalized tonic- clonic seizures alone), as well as ...
The 19th-century Russian novelist Fyodor Dostoevsky had epilepsy and experienced ecstatic seizures. [1] [4] [5] [19] [41] Ecstatic seizures have often been referred to as "Dostoevsky's epilepsy" as he was the first and among the most notable documented cases of the condition.
Epilepsy is a group of non-communicable neurological disorders characterized by recurrent epileptic seizures. [10] An epileptic seizure is the clinical manifestation of an abnormal, excessive, and synchronized electrical discharge in the neurons. [1]