The recruitment and retention of study participants are essential for the success of clinical trials, including Phase 1 clinical trials and 2 studies. Unfortunately, many clinical trials are unable to recruit a sufficient number of study participants to ensure...
In pharmacokinetics, the term dose proportionality is commonly used. If a drug product exhibits dose proportionality, there will be a proportional increase in the amount of drug reaching the systemic circulation, usually expressed in the exposure such as AUC or Cmax,...
Ketamine is a precipitation drug that was developed in the 1960s and approved as an anesthetic. Ketamine has been used on the battlefield to treat injured soldiers in the Vietnam War, in pediatric sedation, and is a medicine widely used in veterinary anesthesia. In...
The process of clinical drug development is complex and associated with high costs and risks. A recent report on drug development found that the overall likelihood for approval of Phase 1 developmental candidates was 7.9% for the time period between 2011 and 2020, and...
Drug discovery and development are crucial to introducing novel therapeutics in clinical practice, and the research in these fields is intensive. In 2020, the Center for Drug Evaluation and Research at the Food and Drug Administration approved 53 novel therapeutics,...
Human abuse potential (HAP) studies, also known as human abuse liability testing, have gained relevance as the FDA becomes increasingly interested in knowing whether or not new drugs could be misused for recreational purposes. Dr. John Oldenhof, Ph.D., Chief...
