Methods and Techniques Used in Drug Development

A selected number of methods and techniques are presented that are widely used during the development of a new drug. They are organised according to the three main development streams. The first section reviews the physico‐chemical, pharmaceutical and analytical methods that are used in the developm...

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Bibliographic Details
Published inGlobal New Drug Development pp. 91 - 168
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
biomarkers
carcinogenicity
cardiovascular safety
Chemical synthesis
chromatography
clinical trial methodology
electrocardiography
formulation technology
genotoxicology
imaging techniques
pharmaceutical development
pharmacokinetics
physico‐chemical methods
quality control
reproductive toxicology
safety pharmacology
spectrometry
toxicology
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Summary:A selected number of methods and techniques are presented that are widely used during the development of a new drug. They are organised according to the three main development streams. The first section reviews the physico‐chemical, pharmaceutical and analytical methods that are used in the development of an active ingredient and a drug product. The second section explains methods and techniques employed in non‐clinical pharmacokinetics, safety pharmacology and toxicology. The final section describes a number of tools used in clinical drug development, some of which are also used in non‐clinical development, and summarises the basics of clinical trial methodology.
ISBN:9781118414880
1118414888
DOI:10.1002/9781118414873.ch4