Biopharmaceuticals respiratory system

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

Separate safety pharmacology studies were completed for many peptides in the survey. Separate safety pharmacology studies are usually performed for NCEs but not biopharmaceuticals. Since rodents are typically used for stand-alone central nervous system and respiratory studies, the usefulness of these studies for NCEs is based on the assumption that rodents are pharmacologically responsive or have some of the same metabolites as would be expected in humans. The lack of concern for metabolism and the significant reduction or absence of pharmacology in rodents with most biopharmaceuticals eliminates the relevance of these studies. In contrast to the larger... 

Cells by themselves or by secreting pharmacologically active substances may have effects on the CNS, cardiac, respiratory, renal, or GI systems. Safety pharmacology should therefore be considered on a case-by-case basis depending on the specific characteristics of the cell-based product [52], In general, specific assessments are made as part of the toxicology assessments rather than as stand-alone studies consistent with the assessments made with protein-based biopharmaceuticals [50]. The fundamental physiological differences (e.g., total blood volume,pulmonary capillary surface area, and volume) should... 

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. 

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. 

However, intensive studies are in progress today in the biopharmaceutical industry for the application of alternate delivery systems, and future advances in medical therapies will depend on new deliveries. These new deliveries may focus on modified parenteral system(s), as well as cavitational, respiratory, gastrointestinal, nasal, dermal, and other areas. In each case, membrane and gastrointestinal barriers must be extensively studied in order to increase bioavailability. 

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