Pharmacology — which is the study of the biomechanical or physiological effects of medicines and drugs on a cell, tissue, organ, or an organism — impacts the design of clinical studies significantly. Preclinical development and the planning stages in particular have a strong emphasis on pharmacology. In 1970, the first World Health Organization report on […]
Understanding the TCL1 oncogene has provided valuable insights for gaining a better understanding of the causal relationship between leukemia and T-cell defects of the immune system. Altered pathways and malignant transformations activated by mutation within the TCL1 oncogene in patients are accurately represented by the TCL1 transgenic mouse model. This animal model has been widely validated […]
Over the past 20 years, the diet in the United States has seen a dramatic rise in the use of added sweeteners, such as high-fructose corn syrup, which in turn has lead to a increase in obesity rates and an epidemic of obesity related diabetes. Diabetes has always been a difficult disease to treat, but […]
If your pharmaceutical company is having difficulty managing the resources necessary to conduct pre-clinical studies, it could be in your best interest to outsource services to a contract research organization (CRO). When it comes to the drug development industry, the growth of CROs is accelerating, according to The Scientist publication. The first CROs appeared in […]
There are instances in drug development where modifications are made to a drug’s composition, formulation, equipment used, or manufacturing processes. These modifications require reassessment of the modified product to ensure the same pharmacological behavior. When a strong in-vitro-in-vivo correlation (IVIVC) is made, it effectively serves as a surrogate to costly in vivo bioequivalence studies, for […]
Before a study reaches Phase I clinical trials, scientists spend years conducting preclinical research. One vital part of this includes performing toxicology research on a particular medication or pharmaceutical product. The U.S. Food and Drug Administration (FDA) put great emphasis on the importance of preclinical safety evaluations. According to the FDA’s guidance for industry on preclinical […]
Many early steps in cancer research began in either animal or tumor models. Without these prototypes, researchers would not have been able to create effective drug treatments or find a cure. In the 1960s, the earliest in vivo tumor models were developed, which were ascites models or murine leukemia models. A paper published in the […]
Wound repair involves a number of highly complex biological processes that can be studied in a comprehensive manner through in vivo studies. Various murine models of wound healing have been effectively utilized to address several wound types. Hundreds of mouse models provide more validated reagents than other animals, and over 1,000 generated mutant loci, often […]
Murine models have served as a mainstay for preclinical cancer research trials for many decades, and continue to provide important insight into factors that influence malignant transformation of a tumor, tumor rate of growth, metastatic disease, and other activities. Two of the most widely used models include the mouse xenograft model and the genetically engineered […]
Researchers and pharmaceuticals in the midst of designing a stronger pre-clinical study will need to understand the ways pharmacokinetics testing can play a role in their trials. Pharmacokinetics is a science that studies how certain substances affect a living organism when administered. This particular science determines what happens to a drug from the time it […]