Biopharmaceuticals cardiovascular system

Biopharmaceuticals Cardiovascular system Central nervous system International Conference on Harmonization Respiratory system Safety pharmacology... 

Another genetic metabolic disorder is Fabry disease, which is related to a deficiency in the enzyme a-galactosidase A. This enzyme is involved in the metabolism of lipids, and its deficiency leads to the accumulation of lipids in the eyes, kidneys, and nervous and cardiovascular systems. In 2001, the biopharmaceutical called Fabrazyme was approved, which consists of recombinant a-galactosidase A and is produced by genetically modified CHO cells. 

The safety pharmacology studies in which the respiratory, CNS, and cardiovascular systems are evaluated in a nonrodent model are not de facto for a biopharmaceutical. Quite frequently the safety endpoints are in the protocols for the pivotal repeat-dose studies, such as a cynomolgus study, obviating the need for separate safety pharmacology studies. 

Safety pharmacology studies in rodent and nonrodent These studies are designed to identify undesirable pharmacological effects in several systems primarily the cardiovascular, respiratory, and CNS systems. Other studies may be included based on the pharmacological activity of the test article. In many cases these studies are not required for biopharmaceuticals and/or may be included in the 4- and 13-week studies and 6- and 9-month studies. 

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