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A chemist from the United States Food and Drug Administration using a high-performance liquid chromatograph (HPLC) to test drug samples to ensure pharmacovigilance

pharmaco- +‎ vigilance.



pharmacovigilance (uncountable)

  1. (medicine, pharmacology) The detection, assessment, understanding and prevention of adverse effects of medicines. [from 1970s]
    • 1987, Veterinary Drug Registration Newsletter, Paris: Office International des Epizooties, ISSN 1010-3538, OCLC 20006147, page 23:
      In our experience, a request concerning suspected drug toxicity (or an adverse effect) needs to be dealt with in greater detail than other chemical agents, to obtain information on the animals affected (species, breed, age, physiological and pathological status) and on the suspect product (conformity, dose administered, storage conditions, etc.). These led us to introduce a specific request form for drugs, called a ‘pharmacovigilance form’, used since October 1988.
    • 2009 August 19, Seema Singh, “NovaLead shows drug repositioning works”, in LiveMint[1], archived from the original on 6 February 2016:
      But it appears repurposing is possible in another crucial phase of drug development—post-marketing surveillance or pharmacovigilance, which essentially identifies adverse side effects of drugs. Experts say “repurposed” pharmacovigilance would look for and understand beneficial side effects of drugs that may surface during their development or use.
    • 2017, Michael Kaeding; Julia Schmälter; Christoph Klika, “The EU Pharmacovigilance System”, in Pharmacovigilance in the European Union: Practical Implementation across Member States, Wiesbaden, Germany: Springer Nature, DOI:10.1007/978-3-658-17276-3, →ISBN, page 22:
      Since it [the European Medicines Agency] began operating in 1995, the agency has become a central actor regarding various aspects of pharmaceuticals regulation and has a crucial role in providing the infrastructure for EU [European Union] pharmacovigilance.


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