1. Introduction

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The data from early on in non-clinical studies help researchers make decisions on the efficacy and safety of the medicine’s development. Such decisions include the conditions and specifications of the marketing authorisation, use of the medicine on the market, pharmacovigilance (post-marketing safety monitoring), and risk management (planning and mitigation).

Non-clinical information is part of the prescription of medicines to patients, e.g., pharmacology or appropriate information for use in pregnancy and lactation. It directs the prescriber (and patients) to the optimal use of the medicine for each patient. For medicines that do not require a prescription (Over the counter, OTC), the relevant information for proper use is given in the Package Leaflet (PL). It is a challenge to give clear directions on non-clinical data in the PL.

Information gathered during non-clinical studies plays a key role in:
  • Decisions on clinical trials.
  • Decisions on marketing authorisation applications.
  • Decisions on post-marketing or monitoring studies.
In addition, the information is used for:
  • First-in-Human studies (based on pharmacology and toxicology data.
  • Clinical studies specific on heart function.
  • Safety monitoring in diverse systems (liver, central nervous system (CNS), renal, etc.).