Determining an appropriate starting dose for first-in-human (FIH) clinical trials is one of the most critical decisions in early-phase drug development. Regulatory guidance from the FDA and EMA encourages the use of scientifically grounded dose selection strategies that incorporate both preclinical toxicity findings and mechanistic pharmacology data. Traditionally, the No Observed Adverse Effect Level (NOAEL)…
Toxicology plays a pivotal role in the preclinical assessment of drugs, guiding the Investigational New Drug (IND) application process. This review summarizes recent advances in toxicological studies relevant to IND applications, including in vitro, in vivo, and computational approaches. Emerging technologies such as organ-on-chip systems, high-throughput screening, and predictive toxicology models are evaluated for their…
Adverse Outcome Pathways (AOPs) are conceptual frameworks that provide a mechanistic understanding of how exposure to a chemical or stressor can lead to adverse outcomes in biological systems. AOPs help connect the molecular initiating event (MIE), which is the initial interaction between a chemical and a biological target, to an adverse outcome at a higher…
Regulatory guidelines in toxicology provide frameworks and recommendations for conducting toxicological studies, assessing the safety of chemicals, and managing potential risks to human health and the environment. These guidelines are developed by regulatory agencies at the national and international levels and serve as important references for industry, researchers, and policymakers. Here are some key regulatory…
Toxicity testing is an essential component of the regulatory evaluation and safety assessment of medical devices. Medical devices are subject to rigorous testing to ensure that they are safe and do not pose significant risks to patients or users. The toxicity testing of medical devices involves assessing the potential adverse effects that the device or…
Nanomaterials, which are materials with dimensions on the nanometer scale (1-100 nanometers), have unique properties and applications across various industries. However, their potential toxicity and impact on human health and the environment have raised concerns. Assessing the toxicity of nanomaterials is crucial for ensuring their safe use and minimizing potential risks. Here are some key…
Toxicokinetics is the study of how toxic substances move into, through, and out of the body. It encompasses the processes of absorption, distribution, metabolism, and excretion (ADME) of toxicants. Understanding toxicokinetics is essential in toxicology as it helps determine the fate of toxic substances in the body, their potential for accumulation, and their ability to…
Biomarkers play a crucial role in toxicology as they provide measurable indicators of exposure to toxic substances and the resulting biological effects. Biomarkers are measurable characteristics that can be objectively evaluated and used as indicators of normal biological processes, pathogenic processes, or responses to exposure to chemical agents. Here are some key aspects and applications…
Dose-response relationships are fundamental concepts in toxicology and pharmacology that describe the relationship between the dose or level of exposure to a substance and the biological response or effect elicited in an organism. It quantifies how the magnitude of a response is related to the amount or concentration of a chemical to which an organism…
Ecotoxicology is the branch of toxicology that focuses on studying the adverse effects of chemical substances on ecosystems and the organisms that inhabit them. It examines how pollutants and contaminants impact various components of ecosystems, including plants, animals, microorganisms, and their interactions with the environment. Here are the key aspects and areas of focus within…