The Dangerous Business of Predicting the Future

Daniel Bar-Shalom; Hannah Batchelor; Linda F. McElhiney; Klaus Rose

doi:10.1007/978-3-031-77240-5_24

The Dangerous Business of Predicting the Future

Daniel Bar-Shalom, Hannah Batchelor, Linda F. McElhiney, Klaus Rose^*

^*Corresponding author for this work

Strathclyde Institute Of Pharmacy And Biomedical Sciences

Research output: Chapter in Book/Report/Conference proceeding › Chapter

Abstract

New drugs do not fall from the sky. Their development has become a complex, expensive, and multidimensional process. There is the past without which we cannot understand the present; the present which this book discusses; and the future. We can extrapolate some technical developments, such as the expanding technique of microencapsulation. The more complex other dimensions are, the more difficult it is to make predictions, specifically where there are interfaces between politics, weltanschauung, and technical developments. Adolescents are legally still children, but no longer physiologically. Adolescents and prepubertal older school children rarely need age-appropriate pediatric formulations. Pointless and/or exaggerated “pediatric” clinical studies in this age group need to be challenged by those working in pharmaceutical development. Formulation development for the benefit of young and very young children and babies is probably the most valuable aspect of pediatric legislation.

Original language	English
Title of host publication	Pediatric Formulations
Subtitle of host publication	AAPS Advances in the Pharmaceutical Sciences Series
Editors	H. Batchelor, K. Rose
Publisher	Springer
Pages	455-457
Number of pages	3
Volume	58
ISBN (Electronic)	978-3-031-77240-5
ISBN (Print)	978-3-031-77239-9
DOIs	https://doi.org/10.1007/978-3-031-77240-5_24
Publication status	Published - 17 Feb 2026

Publication series

Name	AAPS Advances in the Pharmaceutical Sciences Series
Volume	58
ISSN (Print)	2210-7371
ISSN (Electronic)	2210-738X

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

On-label/off-label
Pediatric drug development (PDD)
Pediatric legislation

Access to Document

10.1007/978-3-031-77240-5_24

Cite this

Bar-Shalom, D., Batchelor, H., McElhiney, L. F., & Rose, K. (2026). The Dangerous Business of Predicting the Future. In H. Batchelor, & K. Rose (Eds.), Pediatric Formulations: AAPS Advances in the Pharmaceutical Sciences Series (Vol. 58, pp. 455-457). (AAPS Advances in the Pharmaceutical Sciences Series; Vol. 58). Springer. https://doi.org/10.1007/978-3-031-77240-5_24

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title = "The Dangerous Business of Predicting the Future",

abstract = "New drugs do not fall from the sky. Their development has become a complex, expensive, and multidimensional process. There is the past without which we cannot understand the present; the present which this book discusses; and the future. We can extrapolate some technical developments, such as the expanding technique of microencapsulation. The more complex other dimensions are, the more difficult it is to make predictions, specifically where there are interfaces between politics, weltanschauung, and technical developments. Adolescents are legally still children, but no longer physiologically. Adolescents and prepubertal older school children rarely need age-appropriate pediatric formulations. Pointless and/or exaggerated “pediatric” clinical studies in this age group need to be challenged by those working in pharmaceutical development. Formulation development for the benefit of young and very young children and babies is probably the most valuable aspect of pediatric legislation.",

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author = "Daniel Bar-Shalom and Hannah Batchelor and McElhiney, \{Linda F.\} and Klaus Rose",

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The Dangerous Business of Predicting the Future. / Bar-Shalom, Daniel; Batchelor, Hannah; McElhiney, Linda F. et al.
Pediatric Formulations: AAPS Advances in the Pharmaceutical Sciences Series. ed. / H. Batchelor; K. Rose. Vol. 58 Springer, 2026. p. 455-457 (AAPS Advances in the Pharmaceutical Sciences Series; Vol. 58).

Research output: Chapter in Book/Report/Conference proceeding › Chapter

TY - CHAP

T1 - The Dangerous Business of Predicting the Future

AU - Bar-Shalom, Daniel

AU - Batchelor, Hannah

AU - McElhiney, Linda F.

AU - Rose, Klaus

PY - 2026/2/17

Y1 - 2026/2/17

N2 - New drugs do not fall from the sky. Their development has become a complex, expensive, and multidimensional process. There is the past without which we cannot understand the present; the present which this book discusses; and the future. We can extrapolate some technical developments, such as the expanding technique of microencapsulation. The more complex other dimensions are, the more difficult it is to make predictions, specifically where there are interfaces between politics, weltanschauung, and technical developments. Adolescents are legally still children, but no longer physiologically. Adolescents and prepubertal older school children rarely need age-appropriate pediatric formulations. Pointless and/or exaggerated “pediatric” clinical studies in this age group need to be challenged by those working in pharmaceutical development. Formulation development for the benefit of young and very young children and babies is probably the most valuable aspect of pediatric legislation.

AB - New drugs do not fall from the sky. Their development has become a complex, expensive, and multidimensional process. There is the past without which we cannot understand the present; the present which this book discusses; and the future. We can extrapolate some technical developments, such as the expanding technique of microencapsulation. The more complex other dimensions are, the more difficult it is to make predictions, specifically where there are interfaces between politics, weltanschauung, and technical developments. Adolescents are legally still children, but no longer physiologically. Adolescents and prepubertal older school children rarely need age-appropriate pediatric formulations. Pointless and/or exaggerated “pediatric” clinical studies in this age group need to be challenged by those working in pharmaceutical development. Formulation development for the benefit of young and very young children and babies is probably the most valuable aspect of pediatric legislation.

KW - On-label/off-label

KW - Pediatric drug development (PDD)

KW - Pediatric legislation

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U2 - 10.1007/978-3-031-77240-5_24

DO - 10.1007/978-3-031-77240-5_24

M3 - Chapter

AN - SCOPUS:105030959575

SN - 978-3-031-77239-9

VL - 58

T3 - AAPS Advances in the Pharmaceutical Sciences Series

SP - 455

EP - 457

BT - Pediatric Formulations

A2 - Batchelor, H.

A2 - Rose, K.

PB - Springer

ER -

The Dangerous Business of Predicting the Future

Abstract

Publication series

UN SDGs

Keywords

Access to Document

Other files and links

Fingerprint

Defining a Paediatric Patient

Global Pediatric Legislation for Pediatric Medicines in LMIC Regions

Modeling and Simulation for Pediatric Formulation Development

Cite this