Preclinical feature articles
-
How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals?
5/31/2023
Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.
-
What If We Could Do Clinical Trials Before We Do Clinical Trials?
5/26/2023
New techniques are not only proving to be more effective than animal testing but will herald a completely new way of investigating novel treatments. Using these techniques, like human chip models, medical researchers will be able to actually run “clinical trials” before testing a drug in live humans.
-
More Focus And Funding Becomes Crucial To Curing Colorectal Cancer
4/12/2023
Advancements in the treatment of colorectal cancer have undoubtedly been made in recent years, but unfortunately, they are not enough to combat this deadly disease. Fight Colorectal Cancer President Anjee Davis addresses the critical lack of funding for colorectal cancer clinical trials and treatment options.
-
The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target
3/16/2023
Antibody-drug conjugates (ADCs) are a type of targeted cancer therapy that combines the specificity of monoclonal antibodies with the potency of cytotoxic drugs. This article shares data surrounding the ADCs currently entering clinical trials, a look at failed ADC programs, and more.
-
Tackling Safety Issues Of Adjuvanted Vaccines
3/8/2023
An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.
-
Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations
10/14/2022
This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.
-
Is Phage Therapy Ushering In A Post-Antibiotic Era?
10/3/2022
Faced with the emergence of resistant bacteria, phage therapy, which uses bacterial viruses (bacteriophages) to treat bacterial infections, is emerging as one of the most credible alternatives to antibiotics.
-
A New Pain Treatment Requires Accurate And Reliable Data
9/21/2022
South Rampart Pharma aims to deliver a new, affordable treatment for pain that will avoid the issues with currently marketed products. Opioids are highly addictive; patients taking excessive amounts of acetaminophen can develop liver toxicity; and NSAID over-exposure risks kidney toxicity, gastrointestinal (GI) bleeding, and worsening of high blood pressure in patients with hypertension.
-
Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
9/16/2022
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.
-
Beyond Nuclear Genetics: Let’s Think Differently About CNS Disease Targets
9/12/2022
Nuclear genes with mutations remain the primary focus for selecting biological drug targets, but we have yet to see a drug come to market from a genetically validated target that can arrest or reverse diseases like Parkinson’s. We need to expand our research to explore the essential drivers, genetic or otherwise, that switch our cells from order to disorder or from function to dysfunction.