Format

Send to

Choose Destination
AAPS J. 2016 Sep;18(5):1047-55. doi: 10.1208/s12248-016-9938-6. Epub 2016 Jun 17.

Defining Patient Centric Pharmaceutical Drug Product Design.

Author information

1
Graz University of Technology, Graz, Austria. sven.stegemann@tugraz.at.
2
Capsugel, Bornem, Belgium. sven.stegemann@tugraz.at.
3
Eli Lilly and Company, Indianapolis, Indiana, USA.
4
Centro Medicina dell'Invecchiamento, Department of Geriatrics, Policlinico A. Gemelli, Catholic University of the Sacred Heart, Largo Francesco Vito 1, 00168, Rome, Italy.
5
Texas A&M University, Rangel College of Pharmacy, College Station, Texas, USA.
6
Medicines Evaluation Board, Utrecht, The Netherlands.

Abstract

The term "patient centered," "patient centric," or "patient centricity" is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient's quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that the pharmaceutical drug product design is also adequately addressing the particular patient's needs, i.e., assuring adequate patient adherence and the anticipate drug safety and effectiveness. Relevant pharmaceutical design aspects may e.g., involve the selection of the route of administration, the tablet size and shape, the ease of opening the package, the ability to read the user instruction, or the ability to follow the recommended (in-use) storage conditions. Currently, a harmonized definition on patient centric drug development/design has not yet been established. To stimulate scientific research and discussions and the consistent interpretation of test results, it is essential that such a definition is established. We have developed a first draft definition through various rounds of discussions within an interdisciplinary AAPS focus group of experts. This publication summarizes the outcomes and is intended to stimulate further discussions with all stakeholders towards a common definition of patient centric pharmaceutical drug product design that is useable across all disciplines involved.

KEYWORDS:

drug product design; patient centric; patient characteristic; product characteristic

PMID:
27317470
DOI:
10.1208/s12248-016-9938-6
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Springer
Loading ...
Support Center