Patent
What is a patent?
A patent is a legal right granted to an inventor that provides exclusive rights to make, use, and sell an invention for a specified period.
How many phases are in a clinical trial?
4 -
Phase I: Safety and dosage
Phase II: Efficacy and side effects
Phase III: Large-scale confirmation
Phase IV: Post-marketing surveillance
Define Orphan drugs
very rarely used drugs
What is the basic period of holding patent?
20 years
Bioequivalence studies are mandatory for which type of drugs
Generic drugs
Define Pharmacovigilance
detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, particularly after a drug has been marketed for use in the population.
Which organization regulates drug approval in India?
Central Drugs Standard Control Organization (CDSCO).
what is an unethical marketing practice?
Misleading promotional claims
expand CDSCO.
The Central Drug Standard Control Organisation.
Define generic drug.
A generic drug is a bioequivalent version of a branded drug marketed after patent expiry.
Differentiate between patent and trademark.
Patent - Protects inventions- Valid for 20 years -Technical innovation
Trademark - Protects brand identity -Renewable indefinitely- Logo, name, symbol
What is the significance of post-market surveillance?
To know the drug side effects
What does NDA stand for?
New Drug Application.
What is the role of FDA in drug approval?
The FDA ensures drug safety, efficacy, quality, and regulates manufacturing, labeling, and post-marketing surveillance.