Abstract:
INTRODUCTION:The incidence of kidney dysfunction increases with age and is highly prevalent among patients with hypertension. Since many therapeutic compounds are primarily eliminated through the kidneys, impaired renal function can have negative consequences on drug disposition, efficacy and safety. Therefore, regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have issued detailed guidelines for new drug applications to determine posology requirements for patients with renal impairment. Areas covered: The current review highlights and contrasts agency requirements for pharmacokinetic renal impairment clinical studies. While many of the guidelines are similar among the two agencies, glomerular filtration rate (GFR) determination and reporting differ. Design considerations for a reduced, full or dialysis renal impairment study, as well as modifications to the FDA's draft guidance are discussed. Furthermore, scenarios where pharmacokinetic modelling analysis can benefit a drug development program are also reviewed. Moreover, practical solutions for patient recruitment challenges are addressed. Expert commentary: We summarize how 'one size does not fit all' for GFR assessment, and recommend when to use certain modalities. Finally, we highlight the need for the pharmaceutical industry to engage therapeutic experts to assist in protocol development for renal impairment studies, as these experts understand the nuances of this special population and recommended guidelines.
journal_name
Expert Rev Clin Pharmacoljournal_title
Expert review of clinical pharmacologyauthors
Paglialunga S,Offman E,Ichhpurani N,Marbury TC,Morimoto BHdoi
10.1080/17512433.2017.1274651subject
Has Abstractpub_date
2017-03-01 00:00:00pages
273-283issue
3eissn
1751-2433issn
1751-2441journal_volume
10pub_type
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journal_title:Expert review of clinical pharmacology
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doi:10.1586/17512433.2014.945909
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abstract:INTRODUCTION:Long-acting injectable antipsychotics (LAIAs) were introduced to improve treatment adherence and tolerability of oral formulations. After risperidone was introduced as the first long-acting injectable second-generation antipsychotic, during the last five years olanzapine pamoate, once-monthly paliperidone ...
journal_title:Expert review of clinical pharmacology
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journal_title:Expert review of clinical pharmacology
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journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
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journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
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journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
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journal_title:Expert review of clinical pharmacology
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journal_title:Expert review of clinical pharmacology
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journal_title:Expert review of clinical pharmacology
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journal_title:Expert review of clinical pharmacology
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pub_type: 杂志文章,评审
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journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
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pub_type: 历史文章,杂志文章
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doi:10.1080/17512433.2019.1665026
更新日期:2019-10-01 00:00:00
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journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
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更新日期:2019-04-01 00:00:00
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journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2018.1497973
更新日期:2018-07-01 00:00:00
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journal_title:Expert review of clinical pharmacology
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journal_title:Expert review of clinical pharmacology
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