Drug abuse and potential drug abuse are critical issues for today’s pharmaceutical industry and the health of patients. Understanding the latest FDA regulatory requirements, different study types, relevant timelines and logistics can be challenging. Conducted at a critical stage of drug development, the assessment for drug abuse potential is complex and must be acceptable to regulators.
If a drug or its major metabolite penetrates the brain, then an abuse potential assessment is required, regardless of the therapeutic indication.
Developing a strategy around relevant timelines
The doses for drug abuse testing are selected based on the exposure/plasma levels produced in humans by the highest therapeutic dose. Therefore, drug abuse studies are not recommended until the human therapeutic dose range has been determined; however, your testing strategy should begin much earlier. Continue reading
We are all familiar with cellular metabolism and how the production of ATP (cell energy) is critical for cell development, proliferation, and survival. Understanding the impact of immuno-metabolism and how this area can enhance the ever-evolving immuno-oncology research is a new and exciting field. Since the cells of the immune system are a fundamental component of the tumor microenvironment (TME), cancer immunotherapy continues to be a powerful therapeutic approach to use the immune system to produce an anti-tumor response. Increasing evidence suggests that down regulation of cellular metabolism plays a pivotal role in inhibiting the ability of the immune system to inhibit tumor growth. In the TME, the immune cells are forced to operate with a metabolic disadvantage since they are subjected to a lack of energy resources. This is mainly due to the competition between the immune cells and the tumor cells for limited nutrients.1
Pharmacokinetic (PK) data gathered in the early phases of drug discovery program can provide insights on a compound’s mechanism of action, identify specific attributes of interest and guide decision points to optimize downstream development. Selecting the most appropriate analysis technique is essential to computing PK parameters.
This article discusses how non-compartmental analysis (NCA) of pharmacokinetic data can help support regulatory filings, create predictive simulations and help researchers select lead molecules or formulations. We also explore the topic of data handling as differing approaches and anomalous results can cause delays through investigations and inconsistencies across a program. Finally, we’ll cover unique considerations when working with biologics and the challenges involved with submitting regulatory filings formatted to the Standard for Exchange of Nonclinical Data (SEND) specifications. Continue reading
Over the last decade, Clostridium difficile (C. difficile) infection has rapidly become more prevalent. C. difficile, often abbreviated as C. diff, usually spreads through hospitals and other healthcare facilities, and the elderly are particularly vulnerable. Our society’s overuse of antibiotics has been eliminating normal microbes, allowing C. difficile to take over. Infected patients then release bacterial spores and spread the pathogen to others.
Vaccines are a promising strategy to address this critical public health issue. They are a well-established form of medicine that could be utilized to prevent illness rather than treating an existing infection. While fecal transplants also are being explored, these treatments are very new, and clinicians do not yet know the long-term effects of such procedures. Continue reading