November 29, 2023

Innovator and generics: Pharmaceutical Regulatory Science Notes

Innovator and generics: Pharmaceutical Regulatory Science Notes

A generic drug

According to FDA, “A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics”.

An innovator drug

An innovator drug is the first drugs created containing its specific active ingredient to receive approval for use. It is usually the product for which efficacy, safety and quality have been fully established. When a new drug is first made, drug patent usually will be acquired by the founding company. Most drug patents are protected up to 20 years. During the patent period, other companies cannot make or sell the same drug until the patent expires.

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

Suggested readings: