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Drug Development Scholarly Journals | Open Access Journals
Pharmaceutical Regulatory Affairs: Open Access

Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Drug Development Scholarly Journals

Drug production is the method of getting into the market a new prescription drug after a lead compound is found via the drug discovery process. It requires preclinical research on microorganisms and animals, filing for regulatory status, such as through the United States Food and Drug Administration, for an investigational new product to begin clinical trials on humans, and may include the step of gaining regulatory approval for a new drug application to market the drug. To produce a product that is safe, efficient, and has met all regulatory requirements, any drug development process must proceed through multiple stages. Before a drug can enter a patient, thorough testing must be conducted to determine if it is safe, successful in the treatment of the disorder for which it was developed, and to determine the appropriate dose and proper route of administration.

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Relevant Topics in Pharmaceutical Sciences

Google Scholar citation report
Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

Pharmaceutical Regulatory Affairs: Open Access peer review process verified at publons

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