In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 2 ( 2018-02-11), p. 11-19
Abstract:
The drug approval process is the vehicle through which drug sponsors formally approve a new pharmaceutical for sale and marketing. The goals of the approval process are to provide enough information about the drug safety and efficacy in human beings. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. The approval process starts with preclinical testing. For drugs that appear safe, an investigational new drug application (IND) is filed. If approved, clinical trials begin with phase 1 study that focus on safety and pharmacology. Phase 2 studies examine the effectiveness of the compound. Phase 3 is the final step before submitting a new drug application to the authority. A New Drug Application (NDA) contains all the information obtained during all phases of testing. Phase 4 studies, or post-marketing studies, are conducted after a product is approved.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v1i2.107
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2018
detail.hit.zdb_id:
2738279-5
SSG:
15,3
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