About Sollers

Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

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Process of Drug Development!

Posted by Doctor Dan on Aug 5, 2016 4:08:20 AM

Drug Development involves several processes. The process from the start to end involves a lot of funding and time. Sometimes it may take number of years. Large drug companies usually have in house candidates who carry the development process with a methodical scientific and revolutionary approach to the medical field.

Only a few out of thousands of experiments make it to the medical regulatory approval. This is another reason why new drugs costs higher. The high price is to support the drug development process.

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Important Phases of Drug Development Process

  • Lead Discovery and Proper Utilization: In this phase, the discovered compound is tried and tested. Its mechanism of work is checked and its potential is checked. This determines if it can be introduced in the next stage or should be cut off at this stage.
  • Pre-clinical Development Phase: The new drug is then taken into production and manufacturing. The quantity is not very high and the produced quantum is mainly used for clinical trials. In this phase, the pre-clinical trials are conducted based on a specific data to collect the effects and side-effects under clinical observation. This phase is very important as it determines the suitability of the drug. Its effects on blood and tissues are studied intensively.
  • Application for Investigation of New Drug: The new drug and its proceedings are submitted to the concerned medical bodies and any legal regulatory agencies. The new drug can only be administered on humans after a confirmation form ND.
  • Clinical Development Phase: This phase is long and tedious. Mostly this procedure has three stages. In the first stage, it is tested on healthy individuals. In the second step, it is tested on mid-aged people. In the last and the deciding stage, it is tested on patients. Placebos are given in the third stage to administer the results. After the data has been collected, effects and side-effects are being announced.

Conclusion

After the major steps have been completed, product registration and marketing of the drug is carried out. Soon it is introduced in the medical market through doctors and hospitals.

Topics: Drug Safety