What is Drug Development?
- Discovery and Development
- Preclinical Testing
- Clinical Testing
- Regulatory Review and Approval
- Post-Market Monitoring
The drug development process can take several years, and several millions, if not billions, of dollars.
During discovery, researchers identify a new drug candidate that shows promise through research, experimentation, or sometimes accident. Thousands of compounds may be considered; only a select number may show promise for further development.
The preclinical testing phase uses in vivo and in vitro studies to establish initial dosing, confirm potential efficacy, and expose potential side effects. These studies form the basis of the Investigational New Drug application (IND), which allow the drug candidate to progress to in-human clinical trials.
If the preclinical testing and clinical research proves that the proposed pharmaceutical is safe for humans and effective for its intended use, the sponsor completes the New Drug Application (NDA). If the regulatory authority (e.g. the United States Food and Drug Administration (FDA)) determines the drug is safe and effective, the NDA is approved and the product is made available on the market. Although the IND and NDA processes prove initial safety and efficacy, it is possible unforeseen adverse events will occur over time. Regulatory agencies continue to monitor products in the marketplace for years to come to ensure continued patient benefits.
As a preclinical contract research organization (CRO), Toxikon is well-positioned to support your IND / NDA applications by conducting the full range of testing needed for a successful application.
Preclinical Drug Development Capabilities
- Study design
- Regulatory strategy
- Proof of concept
- Formulation development
- In vivo testing services
- In vitro testing services
- IND/NDA Enabling Studies
- Absorption, distribution, metabolism and excretion (ADME)
- Small and Large Animal Models
- Whole Animal Assays
- Analytical chemistry
- Bioanalytical chemistry
- Cellular biology
Toxikon’s Expertise in Drug Development
With over 40 years of leadership in toxicology, analytical chemistry, microbiology, and biocompatibility, Toxikon is well-positioned to support your IND / NDA applications by providing the full range of preclinical drug discovery testing. Toxikon holds extensive certifications and licenses to meet international regulatory requirements for data quality, acceptability, and harmonization. Choose a preclinical contract research organization you can trust to help you win regulatory approval for your pharmaceutical products.