Exploring the stages of the drug development process with an experimented CRO
The process of drug development constitutes a structured approach to developing and bringing a new drug from initial discovery to market availability. Oncodesign Services supports biotech and pharmaceutical companies from target to IND.
What are the main stages of the drug development process?
Discovery and development phase
This phase involves the identification and research of new drug compounds or molecules that have the potential to treat a specific medical condition or disease. It often begins with laboratory research and testing of thousands of compounds.
Preclinical studies
Before testing a medical compound in humans, preclinical studies are conducted to assess the safety, efficacy, and potential toxicity of the drug candidate. These studies usually involve testing the drug with in vitro assays and in vivo models in laboratories.
Clinical Phase
Clinical trials are conducted in human volunteers to evaluate the safety and effectiveness of the drug candidate. This phase is typically divided into three stages:
- Phase I: Involves testing the drug in a small group of healthy volunteers to evaluate its safety, dosage, and side effects.
- Phase II: Involves testing the drug in a larger group of patients with the target condition to further evaluate its safety and effectiveness.
- Phase III: Involves testing the drug in an even larger group of patients to confirm its effectiveness, monitor side effects, and compare it to existing treatments.
FDA review and approval
After successful completion of clinical trials, the drug developer submits a New Drug Application (NDA) or Biologics License Application (BLA) to regulatory agencies such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. Regulatory agencies review the data to assess the drug’s safety, efficacy, and quality. If the regulatory agency approves the drug, it can be marketed and made available to patients.
Oncodesign Services supports companies in the beginning of the Drug Development Process
Oncodesign Services is a contract research organization (CRO) with over 25 years of experience in early drug discovery and preclinical services, to contribute to the development of innovative therapies against diseases with high medical needs.
We provide research and services in Drug Discovery and Preclinical studies, with integrated solutions in Oncology, Inflammation and Infectious Diseases.
Drug development phases
Oncodesign Services encompasses all the drug development process to deliver drug candidates including:
Find out more about what we can offer you depending on the stage of development of your drug discovery project!
