The Johns Hopkins University Advanced Academic Programs Center for Biotechnology Education is proud to announce the recent publishing of the paper “Patterns of Use and Impact of Standardised MedDRA Query Analyses on the Safety Evaluation and Review of New Drug and Biologics License Applications” by a student group led by AAP instructor Dr. Christopher D. Breder. The paper focuses on how Standardised MedDra Queries are used and their effect on the analyses of drug and biologics applications to the United States Food and Drug Administration (USFDA).
Recent AAP graduates Dr. Samina Qureshi, Riaz Mahmood, and Dr. Lin-Chau Chang, along with Dr. Breder, participated in 16 months of research and data analysis which resulted in the publishing of the paper by PLOS ONE, a science and medicine journal. The students, along with Dr. Breder, who is also a Medical Officer with the USFDA, created a database of over 60 variables related to drug applications to complete a thorough and detailed analysis of over 1350 queries in 184 applications. Congratulations to this dynamic team!