1. Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects.
- Author
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van Riet-Nales DA, Hussain N, Sundberg KA, Eggenschwyler D, Ferris C, Robert JL, and Cerreta F
- Subjects
- Aged, Drug Approval methods, Drug Discovery legislation & jurisprudence, Drug Discovery methods, Drug Discovery standards, Drug Labeling legislation & jurisprudence, Drug Labeling methods, Drug Labeling standards, Drug Storage legislation & jurisprudence, Drug Storage methods, Drug Storage standards, Europe, Geriatrics methods, Humans, Medication Errors legislation & jurisprudence, Medication Errors prevention & control, Tablets standards, Drug Approval legislation & jurisprudence, Drug Design, Geriatrics standards, Motivation
- Abstract
Ageing comes with an increased propensity in the alteration of human organ and body functions, which can e.g. result in multi-morbidity, frailty, polypharmacy, altered medication safety and/or efficacy, and problems with the practical use of medicines in a real world setting. Such problems may e.g. involve difficulties opening containers, swallowing large tablets, breaking tablets by hand, or correctly understanding the user instruction. This review aims to summarize the European regulatory activities towards better medicines for older people, with a main focus on formulation development and the overall drug product design. It addresses the ICH E7 guideline "Studies in support of special populations, geriatrics", the ICH Q8 guideline "Pharmaceutical development", the EMA good practice guide on "Risk minimisation and prevention of medication errors" and the forthcoming EMA CHMP QWP reflection paper on the "Quality aspects (pharmaceutical development) of medicines for older people". In addition, three key aspects to the practical use of medicines by older people are discussed in a wider context: multi-particulates including small tablets (also referred to as mini-tablets), ease of opening and storage conditions. Furthermore, attention is paid to work in progress e.g. incentives by the European national drug regulatory authorities, and patient centric drug product development., (Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2016
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