Bringing a new drug to market is not a simple task and due to regulations and high costs associated with the process, drug developers often pass on conducting optional testing. Ototoxicity is one example of a frequently forgone test as it’s not required by the FDA for medications that are not administered into the ear. […]
For drugs administered into the middle ear, those expected to come in contact with the middle or inner ear tissues, or drugs in a class of risk for ototoxicity, auditory safety evaluations are recommended. These assessments require a highly specialized set of tests to obtain the necessary data in order to identify the ototoxicity of […]
Certain medications can damage the ear, resulting in hearing loss, ringing in the ears, hyperacusis, or balance disorders. Thus, many drugs should be tested for auditory safety prior to going to market. While some contract research organizations (CROs) offer ototoxicity services, portions of the studies are often outsourced to other specialized shops or academic labs. […]
Mattawan, Mich. – MPI Research today announced it has named Susan L. Buckham, MS, as its new Vice President of Operations. In this role, Susan will be responsible for the strategic leadership and overall direction of operational activities for all functional areas involved with the coordination and execution of in vivo studies. In addition, she […]
Mattawan, Mich. – MPI Research announced it has completed the validation of its Instem submit™ software suite, allowing for the creation of consistent, accurate, and high quality datasets compliant with the Standard for Exchange of Nonclinical Data (SEND).
Initially powered by the FDA’s Critical Path Initiative to more efficiently bring medical breakthroughs to market, SEND supports […]
The primary objective of safety pharmacology studies is to identify potential adverse functional effects of a compound on the central nervous, respiratory, or cardiovascular systems.
Like many areas of drug development, safety pharmacology is a rapidly progressing industry segment. The technologies and tools available to conduct these studies are evolving and expanding regularly. A critical—and quickly […]