The extensive timeline to develop a drug is due to a multitude of formulation challenges that formulation experts face. When it comes to solving these challenges, there have been significant advancements in drug development techniques to counter these challenges including bioavailability, stability, efficacy, manufacturability, and safety.
With proactive planning and validated processes, NK cell functional analysis can support a range of various immunotoxicity endpoints in a study, from discovery and development to the clinic.
Phase I is often seen as the gateway between scientific research and clinical medicine, and the outcome of the trials have a major impact on the next steps of any prospective drug.
The ongoing advances in cancer immunotherapy together with precision medicine may promise a bright future for patients. Learn about the two most common biomarkers in clinical trials that are critical for the drug development process.
Medical research has seen a great deal of high-profile philanthropic investment in recent years. Last year, for example, tech billionaire Sean Parker made a $250 million donation to further the development of immunotherapy. More recently, the Chan Zuckerberg Biohub has made headlines by announcing plans to invest $3 billion in new research over the next 10 years. The investment is part of the Biohub’s ambitious goal of curing all disease by the end of the century. It will be directed toward a wide array of medical solutions including new drugs, vaccines, and diagnostic tests - and the first round of grant recipients has already been chosen.
Identifying the optimal formulation and dose form which shows an increase more than 20 times in the oral bioavailability of Salmon Calcitonin.
The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems.
Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted.
Cancer continues to be a formidable disease with an overall success rate of bringing new drugs to market of only 5-8%.
An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.
PRA is a global Clinical Research Organization providing services through all phases of clinical development. PRA has supported over 3,100 clinical trials in more than 80 countries on 6 continents through our global offices. PRA's therapeutic expertise, global reach, and project experience with local knowledge enable our project teams to deliver consistent and on time performance for our clients.
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.