Learn about the Non-clinical drug development, goals and objectives. It is a process involving evaluation of safety and efficiency of drugs.
What is Non-Clinical Drug Development?
Non-clinical drug development or pre-clinical drug development is a risk process involving evaluation of safety and efficiency of drugs in animal drugs. Generally, pre-clinical studies are conducted to determine the safety and efficiency of drug data in animal. Before using a new medicinal product in human, its safety and efficiency is tested in animals this is known as a pre-clinical study. The pre-clinical studies also require approval from the regulatory authorities that should assure that the clinical trials are being performed safely and should give approval only for safe and effective drugs. ICH has put down some basic guidelines, which summarize technical necessities of satisfactory pre-clinical drug development.
Goals and Objectives
Here are the goals and objectives of non-clinical drug development:
- Choose the best drug molecules during discovery.
- Access the safety and how the drug is absorbed for human trials.
- Evaluate safety for extended use, including pregnant women and children, combinations with other drugs, new formulations and administration methods.
- Determine if the drug may cause cancer.
- Study how the drug toxicity works in human body.
- Examine the toxicology and genotoxicity of drug impurities.
- Ensure the safety of intermediates in drug manufacturing for workers.
- Determine the safety of substances used in drug formulations.
- Investigate how the drug is toxic in translational research.
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FAQ
1.What is the purpose of pre-clinical studies in drug development?
Answer: The primary purpose of pre-clinical studies is to evaluate the safety and efficiency of drug candidates in animals before testing them in humans. This ensures that new medicinal products are safe and effective before they are used in human clinical trials.
2. Why is it essential for pre-clinical studies to receive approval from regulatory authorities?
Answer: To ensure that clinical trials are conducted safely, and that approval is granted only for safe and effective drugs.
3.What are some of the key objectives of non-clinical drug development?
Answer: Key objectives of non-clinical drug development include:
- Selecting promising drug candidates during discovery.
- Determining safety and bioavailability for human trials.
- Evaluating safety for extended use (pregnant woman or child).
- Determining carcinogenicity.
- Understanding drug toxicity mechanisms.
- Examining the safety of drug impurities, intermediates and excipients.
4.What is the significance of ICH guidelines in pre-clinical drug development?
Answer: ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines provide technical necessities and standards for satisfactory pre-clinical drug development. They ensure that the drug development process is consistent and aligned with global standards.
5.What percentage of drugs that successfully complete the pre-clinical phase typically reach the market?
Answer: Approximately 20% of drugs that successfully complete the pre-clinical phase go on to reach the market.
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