Articles by Anke Rosch

  1. Rats Behind The Wheel: The Right Preclinical Way To Investigate Drug Effects On Driving? 12/8/2025

    What can we do preclinically for drug-induced impairment of driving ability? This article reviews the causes, regulatory environment, and limitations.

  2. Should We Explore Suicidality In Animals During Preclinical Drug Development? 11/19/2024

    An adverse side effect for some drugs is suicidal ideation and behavior (SIB). Investigating SIB in animal studies represents the closest approximation to human SIB, yet the FDA Modernization Act 3.0 obligates us to reduce unnecessary animal testing. Let's examine this with data-driven research.

  3. Animal Testing Isn't Perfect. Is There An Alternative? 1/8/2024

    Statistics have been showing that rodent and non-rodent experiments predict human toxicity in only 48-71% of drugs. The FDA Modernization Act 2.0 of 2022 permits the use of suitable animal-free new approach methodologies, and the European Parliament launched a program to eliminate animal studies "as soon as scientifically possible." Let's take a data-driven, research-driven look at the topic.

  4. 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.

  5. 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.

  6. 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.