Global New Drug Development: An Introduction
The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. Discovering and bringing one new drug to the public typically costs a pharmaceutical or biotechnology company on average more than $1 billion and takes an average of 10 to 15 years. A must have book for students and professionals in the field of medicine and pharmacology.
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