The Early Development of a New Drug

The early development of a new drug is the phase that bridges late discovery with the Proof‐of‐Concept (PoC) in patients. It is divided into a pre‐clinical and a clinical phase. The pre‐clinical phase includes all the preparatory work before the First‐in‐Human (FIH) study, while the early clinical p...

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Bibliographic Details
Published inGlobal New Drug Development pp. 169 - 252
Main Authors Rosier, Jan A, Martens, Mark A, Thomas, Josse R
Format Book Chapter
LanguageEnglish
Published United Kingdom Wiley 2014
John Wiley & Sons, Ltd
Subjects
clinical development
Early drug development
First‐in‐Human (FIH) study
formulation research
non‐clinical development
pharmacokinetics
phase 1
phase 2a
Proof‐of‐Concept (PoC)
safety pharmacology
toxicology
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Summary:The early development of a new drug is the phase that bridges late discovery with the Proof‐of‐Concept (PoC) in patients. It is divided into a pre‐clinical and a clinical phase. The pre‐clinical phase includes all the preparatory work before the First‐in‐Human (FIH) study, while the early clinical phase is meant to explore the effects of the new drug candidate in humans, usually first in healthy volunteers and later in patients. For each of the two phases, the chemical/pharmaceutical, non‐clinical and clinical development is discussed in detail. At the end of each phase, the integration of all the data gathered is presented, and how this leads to the formal decision to progress (or not) to the next phase of drug development.
ISBN:9781118414880
1118414888
DOI:10.1002/9781118414873.ch5