Proof of Concept

What is a Proof of Concept in Preclinical Pharmacology?

Identifying a suitable drug can be time-consuming and complex, taking as long as 15 years from initial design to receiving market approval. Each stage of the drug development process is crucial and encompasses a multitude of tests and results which will be used to make decisions about the efficacy and safety of a drug and whether scientists should continue to develop them. Preclinical pharmacology is just one part of the drug development process, in which proof of concept is a must-have study.

Here, we provide an overview of what a proof of concept study is and what support is available at Oncodesign Services for conducting one.

An Overview of Preclinical Pharmacology

Preclinical pharmacology is a stage in drug development, consisting of many activities, that determines whether a drug is accepted for human clinical trials. In this stage, also known as preclinical studies, a drug is extensively tested to analyze its biologicl activity, adverse effects, and its ADME properties (absorption; distribution; metabolism; and excretion). Clinical trials are closely monitored by agencies such as the Food and Drug Administration (FDA) in the USA.

There are four main sections to preclinical studies: drug discovery, formulation development, pharmacology, and toxicology. In preclinical pharmacology, tests are carried out in vivo models to gain a deeper understanding of a drug. Its ADME results provide information about the pharmacokinetics and pharmacodynamic including safety information.

What is a Proof of Concept?

In the early stages of drug development, proof of concept studies are conducted as a risk assessment to determine a drug’s feasibility. Proof of concept studies contributes to the decision of whether to continue developing a new product through preclinical and clinical stages, which are costly and time-consuming, making it crucial to the process.

During any proof of concept study, multiple activities will help gather evidence about the product. These include background research, clinical research, biomarker selection, research into side effects, and human abuse potential, to name a few.

Proof of concept studies can be tailored to your research program depending on the product and testing paraments required. However, because of how vital these studies are in preclinical pharmacology, many experienced companies offer proof of concept and more comprehensive preclinical pharmacology package.

By partnering with a specialist drug discovery contract research organization (CRO), you can enhance your throughput, reduce bench-to-bedside timelines and benefit from expert advice throughout your preclinical studies.

Oncodesign Services offers integrated services in Preclinical Pharmacology

Oncodesign Services comprises a multidisciplinary team with the skills and expertise required to lead the preclinical pharmacological characterization of drugs, which includes in vivo testing, proof of concept, and other services.

Through our  integrated services (INPACT), Oncodesign Services guide you through proof of concept for your drug discovery projectin oncology, immuno-inflammation, and infectious diseases. Our offer covers a wide range of services, which include the following:

• A dedicated, experienced team of scientists to support you through your project
• A ‘one-stop-shop’ business model designed to optimize production times and results
• A preclinical pharmacological development plan that matches your product profile
• Project management designed to meet your requirements
• Regular support and discussions

Contact a member of the Oncodesign Services team today for more information on Proof of Concept studies or to learn more about the preclinical pharmacology stages.