Introduction:
The process of bringing a new drug from idea to market is complex, involving a series of well-defined steps, a series of rigorous stages, from initial discovery and preclinical testing to clinical trials and regulatory approval. In this blog, we will examine the details of a new drug development process, explore steps to be taken, regulations for developing drugs and their role in chemical databases, with particular emphasis on Indian and global scenarios.
Novel Drug Development:
1. Discovery and Research:
- Identifying a potential target for drug development, often a specific molecule or biological pathway that is associated with certain diseases, is the first stage of this process.
- Using a variety of instruments and techniques, including high-throughput screening as well as computing methods, researchers carry out large studies in order to gain an understanding of the objective.
2. Preclinical Studies:
- In order to assess safety, efficacy and potential adverse reactions, a promising compound is subjected to preclinical testing in laboratory and animal models when it has been identified.
- In order to inform the design of subsequent clinical studies, researchers produce valuable data on pharmacokinetics, pharmacodynamics and toxicity.
3. Investigational New Drug Application:
- Before moving to human trials, researchers submit an IND application to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), providing comprehensive data from preclinical studies.
- The initiation of clinical trials is facilitated by the approval of an Investigational New Drug application.
4. Clinical proceedings:
- In order to evaluate safety, dosage, efficacy and side effects of the medicinal product in human subjects, this stage consists of three stages: Phase I, II and III clinical studies.
- In order to evaluate safety, dosage, efficacy and side effects of the medicinal product in human subjects, this stage consists of three stages: Phase I, II and III clinical studies.
5. New Drug Application (NDA) Submission:
- The successful completion of clinical studies allows the submission of a New Drug Application to regulatory authorities for marketing authorization.
- In order to ensure the safety, efficacy and quality of the medicinal product before it is given marketing authorization, the NDA shall be reviewed by regulators.
6. Post-Marketing Surveillance:
After approval, it is essential to continue monitoring the safety and efficacy of the medicinal product for any unusual or long term adverse reactions which may not be detected in human studies.
Regulatory guidelines for drug development:
There are strict laws and regulations governing the drug development process. The Basic Law of the United States is a Federal Food, Drug and Cosmetic Act to ensure that medicines are safe and effective. The process of drug development in India is governed by the new rules on drugs and clinical trials, published in 2019. (Courtesy: Statista.com)
Indian and Global Scenario:
In 2023, Indian pharma industry has achieved a tremendous growth, having approx. 5,500 companies with current R & D facilities. At global level pharma industries also performed well as 21,000 molecules were in R & D pipeline last year. (Courtesy: Statista.com)
Chemical Databases and Chemxpert Database:
Data Related Drug Discovery:
- Drug related databases has pivotal role in the drug discovery as these offer vast knowledge of chemicals and other valuable information.
Chemxpert Database:
Conclusion:
In a nutshell, it is a complex journey that requires collaboration, regulatory compliance and access to reliable chemical databases in order to develop new medicines. The world's pharmaceutical progress is significantly helped by emerging economies such as India. In particular, the Chemxpert database is a major driver of drug discovery and development. The industry is being shaped by technology and collaboration efforts, with databases such as Chemxpert playing an important role in the future of health.
