Authors :
Darade Jyoti Sambhaji; Pramod B. Tidke; Dr. Sandip .V. Phoke
Volume/Issue :
Volume 9 - 2024, Issue 3 - March
Google Scholar :
https://tinyurl.com/2zmc45kr
Scribd :
https://tinyurl.com/2y53w2ms
DOI :
https://doi.org/10.38124/ijisrt/IJISRT24MAR495
Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.
Abstract :
There are distinct regulatory approval
processes needed in the discovery and development of
novel medications. Finding new pharmaceuticals requires
extensive study in the fields of chemistry, production,
control, pre-clinical science, and clinical trials.
The next step is to submit an IND after new
medications are identified. The primary goal of the IND
application is to obtain approval for human subjects
clinical trials (Phase 1, 2, and 3). The next step once
clinical trials are finished is the New Drug Application
(NDA). The primary goal of the NDA application process
for the development of new drugs is obtaining approval to
sell the medications on the open market. Once the patient
has passed away, the sponsor should apply to the ANDA
right away. Obtaining authorisation for the sale of the
generic medication is the primary goal of the
ANDA.ANDA state that Abbreviated New Drugs
Approval that are used for the generic drug approval.
Keywords :
Drugs Approval Process_INDA (Investigational New Drugs Application), NDA(New Drugs Application) and ANDA(Abbreviated New Drugs Application).
There are distinct regulatory approval
processes needed in the discovery and development of
novel medications. Finding new pharmaceuticals requires
extensive study in the fields of chemistry, production,
control, pre-clinical science, and clinical trials.
The next step is to submit an IND after new
medications are identified. The primary goal of the IND
application is to obtain approval for human subjects
clinical trials (Phase 1, 2, and 3). The next step once
clinical trials are finished is the New Drug Application
(NDA). The primary goal of the NDA application process
for the development of new drugs is obtaining approval to
sell the medications on the open market. Once the patient
has passed away, the sponsor should apply to the ANDA
right away. Obtaining authorisation for the sale of the
generic medication is the primary goal of the
ANDA.ANDA state that Abbreviated New Drugs
Approval that are used for the generic drug approval.
Keywords :
Drugs Approval Process_INDA (Investigational New Drugs Application), NDA(New Drugs Application) and ANDA(Abbreviated New Drugs Application).
