Pigs share many physiological, anatomical, and metabolic similarities to humans making them a great model. Recently, there has been an increased demand to use miniature pigs as a non-rodent species for pharmacology and toxicology studies as part of pre-clinical drug safety testing. Typically, these tests require more than 8 blood collection time points over a 24 hour period and the same pig may be used to evaluate multiple dose levels or for multiple studies resulting in many blood collections per animal. Additional blood vessel access may also be required for test articles administered intravenously (IV).
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Frontage's Chris Ryan shares experiences and stories, as well as suggestions for how to set up a successful IND approach. We hope you will find our discussion insightful and help you avoid unexpected surprises in your IND-directed studies.
Chris Ryan is Senior Director of Business Development with Frontage Laboratories, Inc. supporting non-clinical safety and toxicology and drug metabolism and pharmacokinetics (’DMPK’) for pharma and biotech clients’ drug development programs. Mr. Ryan has worked for several Contract Research Organizations in drug development for over 18 years. As a former project manager for IND-directed programs, he has helped dozens of companies work through the complexities of pre-clinical safety and toxicology programs.
Intraperitoneal (IP) dose administration: Successful Testing in Dogs Using IP Catheters with Access Ports
Intraperitoneal (IP) dose administration is the preferred method of dosing in the treatment of certain cancers as well as for peritonitis. Unfortunately, replicating IP administration in dogs in order to evaluate drug toxicity has posed multiple, serious challenges, rendering the approach unworkable in the laboratory. It is possible, however, to overcome these challenges by using a modified catheter with an access port to administer the investigational product. Frontage Labs has successfully applied this technique in dosing dogs as part of a study of a chemotherapy drug for ovarian cancer, demonstrating the viability of this method.
Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21 percent in 2013. In other words, “efforts to remove unsafe agents earlier in the development cycle are paying off.” Much of this success in small molecules relates to careful and methodical work done well before the Investigational New Drug (IND) application.