A review of clinical pharmacology deficiencies of European centralised drug marketing authorisation applications
| Autor: | Jane O’Sullivan, Alexandra-Roxana Ilie, Susan M. Cole, Essam Kerwash, Justin L. Hay |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Drug marketing
Biological Availability Target population 010501 environmental sciences Toxicology 030226 pharmacology & pharmacy 01 natural sciences Risk Assessment law.invention Orphan drug 03 medical and health sciences 0302 clinical medicine Government Agencies Drug Development law Agency (sociology) Medicine Humans Drug Approval 0105 earth and related environmental sciences Marketing of Health Services Clinical pharmacology Dose-Response Relationship Drug business.industry Authorization General Medicine Europe Drug development Therapeutic Equivalency Consumer Product Safety Pharmacology Clinical Government Regulation Observational study Engineering ethics business |
| Zdroj: | Regulatory toxicology and pharmacology : RTP. 118 |
| ISSN: | 1096-0295 |
| Popis: | The aim of this observational review was to review trends in deficiencies in clinical pharmacology dossiers by analysing the frequency and characteristics of major objections (MOs) related to clinical pharmacokinetics and dose-exposure-response (DER) relationships in assessment reports for medicinal products submitted in centralised procedures to the European Medicines Agency (EMA). Initial Assessor (Day 120) assessment reports between 2013 and 2018 were reviewed MOs and characterised with regards to ATC code, orphan status, legal basis and type of molecule, major objection topic and if scientific advice had been sought during development. 23% of the 551 identified Day 120 assessments contained at least one major objection related to clinical pharmacology. Most common topics identified were related to the pharmacokinetics in the target populations, analytical methods, dose-exposure-response relationships, absorption, distribution, metabolism, excretion, comparative bioavailability, and bioequivalence issues. The importance of a robust clinical PK dossier in the assessment of marketing authorisation applications was highlighted by the high frequency of major objections. This review should provide valuable insights to ensure that aspects of bioanalytical methods, comparative bioavailability, PK in the target population and DER relationships are thoroughly addressed in future marketing authorisation applications. |
| Databáze: | OpenAIRE |
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