Articles by Anke Rosch

1. How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals? 5/31/2023

   Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.

2. Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations 10/14/2022

   This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.

3. Sex Matters… In Preclinical Drug Development? 1/18/2022

   In safety pharmacology studies investigating short-term side effects on physiological functions, the scientist is obliged to “consider” sex in the study design of animal models. This article also shares the differences in anxiety and depression in human males and females.