For the development of new drugs, there is a requirement for investment of major capital, human resources and scientific expertise. Not only are stringent regulations required on testing and manufacturing standards of the drug, there is also the general population healthcare requisite which needs to be met with the limited resources and technology available.
For a new drug to reach the market, it takes more than a decade and several tests and trials that the FDA needs to clear. The information for the pre-clinical testing and the new molecular entity (NME) is submitted by a New Investigational Drug (IND) document to the FDA and if approved, it moves to the clinical phases.
There are 4 clinical phases that need to be cleared and if the tests are positive with an acceptable toxicity and safety profile of the investigational drug, then the drug is submitted for a marketing approval. This is known as a New Drug Development (NDA) document in the United States.
The IND is submitted by the Sponsor (pharmaceutical company) to gain permission from the FDA to ship an experimental drug across state lines before the marketing plan has been approved. The FDA primarily checks that the human subjects will not be abused by any unnecessary risk during the clinical trials. If approved by the …show more content…
In each phase of the clinical trial, substantial information needs to be submitted to assure proper identification, quality, purity and strength of the investigational drug. Also, the information available will vary with the phase of the investigation. For example, the stability data of a drug is required in all phases of an IND to show that the new drug product is acceptable within the chemical and physical limits of the proposed investigation, however, if for any reason there are short term clinical tests planned during the trial, the supporting stability data can be
For a new drug to reach the market, it takes more than a decade and several tests and trials that the FDA needs to clear. The information for the pre-clinical testing and the new molecular entity (NME) is submitted by a New Investigational Drug (IND) document to the FDA and if approved, it moves to the clinical phases.
There are 4 clinical phases that need to be cleared and if the tests are positive with an acceptable toxicity and safety profile of the investigational drug, then the drug is submitted for a marketing approval. This is known as a New Drug Development (NDA) document in the United States.
The IND is submitted by the Sponsor (pharmaceutical company) to gain permission from the FDA to ship an experimental drug across state lines before the marketing plan has been approved. The FDA primarily checks that the human subjects will not be abused by any unnecessary risk during the clinical trials. If approved by the …show more content…
In each phase of the clinical trial, substantial information needs to be submitted to assure proper identification, quality, purity and strength of the investigational drug. Also, the information available will vary with the phase of the investigation. For example, the stability data of a drug is required in all phases of an IND to show that the new drug product is acceptable within the chemical and physical limits of the proposed investigation, however, if for any reason there are short term clinical tests planned during the trial, the supporting stability data can be