PMC:7554011 / 3078-4697 JSONTXT

{"target":"http://pubannotation.org/docs/sourcedb/PMC/sourceid/7554011","sourcedb":"PMC","sourceid":"7554011","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7554011","text":"Defining appropriate biorelevant drug dissolution conditions requires an understanding of the relationship between the various physicochemical and physiological factors that have an impact on the rate and extent to which an orally administered dosage form is absorbed (4). Since clinical research with adults cannot simply be generalised or extrapolated to the paediatric population, research involving paediatric patients is essential (6). Age-related PK studies are normally required due to differences in anatomy or drug handling/manipulation practices, which might lead to different dose requirements to achieve efficacy or to avoid adverse effects (7). Moreover, changes in developmental physiology throughout childhood complicate pharmacotherapy, due to its impact on drug absorption, distribution, metabolism and excretion of drugs and excipients (8). Thus, better understanding of physiological developmental changes is important for paediatric drug testing. Data characterising the GI environment of the different paediatric age groups is very difficult to be obtained due to ethical constraints, associated co-morbidities in paediatric patients and the need for parental consent. Challenges in paediatric medicine development further include (i.) the need for appropriate outcome measures for paediatric patients, (ii.) the complexities of paediatric administration practices (e.g. drug manipulation and mixing with food and drinks (vehicles)), (iii.) the parental involvement and (iv.) the adaptations of required research procedures and settings to accommodate paediatric anatomic/cognitive development (8).","tracks":[{"project":"2_test","denotations":[{"id":"33051713-24189013-26778","span":{"begin":437,"end":438},"obj":"24189013"},{"id":"33051713-27704550-26779","span":{"begin":654,"end":655},"obj":"27704550"}],"attributes":[{"subj":"33051713-24189013-26778","pred":"source","obj":"2_test"},{"subj":"33051713-27704550-26779","pred":"source","obj":"2_test"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"2_test","color":"#ece393","default":true}]}]}}