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Ronald R M, Moorthy K, Marianne R S, Taylaur W P, Rocio A, Anica S-B et al

1990 Jun;87(12):4879-83

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Key objectives of pharmacovigilance in clinical trials include: Early identification of adverse drug reactions Continuous monitoring of benefit-risk balance Compliance with global regulatory requirements Protection of trial participants Supporting regulatory decision-making Effective pharmacovigilance systems ensure that safety concerns are detected promptly and that appropriate regulatory actions can be taken when necessary