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Novel Disease Models for Choroidal Neovascularization Studies

Choroidal neovascularization (CNV) involves the development of new blood vessels that originate from the choroidal layer of the eye and invade the outer retina. CNV is the hallmark lesion of wet macular degeneration, a more advanced type of age-related macular degeneration (AMD) responsible for severe vision loss. Developing effective new treatments for CNV requires accurate […]

By | 2017-09-19T15:38:40+00:00 September 19th, 2017|Blog|Comments Off on Novel Disease Models for Choroidal Neovascularization Studies

Risks and Effects of Ototoxic Medications

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. […]

By | 2017-08-16T13:07:50+00:00 August 16th, 2017|Blog|Comments Off on Risks and Effects of Ototoxic Medications

Key Considerations in Ototoxicity Study Design

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 […]

By | 2017-07-04T10:26:10+00:00 May 24th, 2017|Blog|Comments Off on Key Considerations in Ototoxicity Study Design

The Benefits of In-house Ototoxicity Work

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. […]

By | 2017-07-04T10:26:11+00:00 April 28th, 2017|Blog|Comments Off on The Benefits of In-house Ototoxicity Work

Optimizing Safety Pharmacology Programs to Promote Efficiency and Animal Welfare

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 […]

By | 2017-07-04T10:26:13+00:00 October 7th, 2016|Blog|Comments Off on Optimizing Safety Pharmacology Programs to Promote Efficiency and Animal Welfare

To BDC or Not to BDC – That Is the Question

Andrew Augustine, MS, Senior Study Director, DMPK

One of the primary functions of the liver is to manufacture bile, which is necessary for the digestion of fat and elimination of drugs and their metabolites. Metabolism of drugs by the liver determines clearance and bioavailability. Rats are typically the first species used to characterize drug clearance, bioavailability, […]

By | 2017-07-04T10:26:16+00:00 September 1st, 2016|Blog|Comments Off on To BDC or Not to BDC – That Is the Question

Lessons Learned in Preparing Nonclinical Programs Part I:

Test Article Considerations

Effects: Sharing as much information as you can with your contract research organization (CRO) about your test article and its known or potential effects is a critical component of the study design process. Have in-depth discussions about the structure, class, intended use, mechanism of action, previous findings, and anything else that may affect […]

By | 2017-07-04T10:26:21+00:00 July 10th, 2016|Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part I:

Lessons Learned in Preparing Nonclinical Programs Part II:

Species Selection

The basic question that helps to address this is “what is your test article type?”.  For small molecules, invariably there will be two species needed; a rodent and a non-rodent, while for a biopharmaceutical it could be either one species or two species. While there is public pressure to minimize the use of species […]

By | 2017-07-04T10:26:25+00:00 July 9th, 2016|Homepage Featured, Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part II:

Lessons Learned in Preparing Nonclinical Programs Part III:

Analytical/Bioanalytical Methods

Validated analytical/bioanalytical methods will be required to determine the amount of drug administered to the animals, the amount of circulating drug in the serum/plasma, and the presence of antibodies against the drug (applies only to biopharmaceuticals) in the serum.  Depending on your project, you may also need analytical methods for other matrices such as […]

By | 2017-07-04T10:26:27+00:00 July 8th, 2016|Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part III:

Lessons Learned in Preparing Nonclinical Programs Part IV:

Administrative Issues

Contracts: When outsourcing your work to a CRO, you need to ensure that you are protected from a legal standpoint.  There are two basic contracts that you will need.  The first is a confidentiality contract (also called a CDA or NDA), which will protect any conversations you have with the CRO as being privileged […]

By | 2017-07-04T10:26:32+00:00 July 7th, 2016|Lessons Learned: Nonclinical Programs|Comments Off on Lessons Learned in Preparing Nonclinical Programs Part IV: