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 […]
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 […]
The design of pre-clinical studies is a complex task, and understanding the translation from animal model to human diseases requires a great deal of care and a high level of understanding of both the basic science and the clinical condition. Many drugs in clinical development flounder due to lack of efficacy or unacceptable side effects. […]