Preface

No matter how elaborate the preclinical and clinical phases of drug development are before a drug is approved, unless the drug hits the market and is in efficient use, its safety information is not fully elucidated. This is where signal detection in pharmacovigilance comes in. Signal detection is the process of using statistics and other data to determine new or changing risks of drugs. If a drug is approved for the market, this means that it showed a positive or predominating benefit-to-risk ratio that satisfied the relevant medical and statistical criteria. However, meeting such criteria does not mean that the drug's safety profile or "signal" is fully determined. A quantitative signal detection is a promising approach that helps in the early identification of new, rare reactions (desired or undesired) of a drug. Determining the safety information of marketed medicines is a continual process. Pharmacovigilance was the first method developed for post-marketing surveillance, and despite its inherent limitations such as lack of information or underreporting, it is still the main method for determining drug safety. This book presents a comprehensive overview of pharmacovigilance and signal detection.

The editor would like to thank all the authors for their excellent contributions.

**Charmy S. Kothari and Manan Shah**

Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, India

**1**

Section 1

Pharmacovigilance
