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Role of Innovator Product Characterization in Generic Product Development

  • Bhushan Munjal
  • Vishal Koradia
  • Sai HS. Boddu
  • Arvind K. Bansal
Chapter

Abstract

Generic drug products are defined as drug products that are comparable to the innovator/reference listed drug products (RLD) in dosage form, strength, route of administration, quality and performance characteristics, and intended use. These products play a critical role in the healthcare systems and contribute to more than 50 % of the total prescriptions by volume. Generic products are accorded regulatory approval based on the concept of therapeutic equivalence to the RLD. Therapeutic equivalence comprises of pharmaceutical equivalence and bioequivalence. Speed to the marketplace is the key for success in generic market. Development of generic products can be accelerated by performing characterization of the RLD, also referred as de-formulation studies. These studies, related to quantification of critical excipients, and solid state characterization of the active pharmaceutical ingredient, could provide critical inputs for formulation development of generic products. This chapter highlights the role of innovator product characterization in accelerating formulation development of generic products. Role of such studies in simplifying regulatory approval process has also been highlighted.

Keywords

Abbreviated new drug application Generic drug Innovator drug Reference listed drug Deformulation 

Abbreviations

ANDA

Abbreviated new drug application

API

Active pharmaceutical ingredient

CFR

Code of federal regulations

FTIR

Fourier transform infrared spectroscopy

HPLC

High performance liquid chromatography

HPMC

Hydroxypropyl methylcellulose

HPTLC

High performance thin layer chromatography

LC-MS

Liquid chromatography-mass spectrometry

MCC

Microcrystalline cellulose

NDA

New drug application

NIR

Near infrared spectroscopy

NIRCI

NIR Chemical Imaging

PEG

Polyethylene glycol

PSD

Particle size distribution

QbD

Quality by Design

RLD

Reference listed drug

USFDA

United States Food and Drug Administration

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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Bhushan Munjal
    • 1
  • Vishal Koradia
    • 2
  • Sai HS. Boddu
    • 3
  • Arvind K. Bansal
    • 1
  1. 1.Department of PharmaceuticsNational Institute of Pharmaceutical Education & Research (NIPER)SAS NagarIndia
  2. 2.Technical Research & DevelopmentNovartis Pharma AGBaselSwitzerland
  3. 3.Department of Pharmacy PracticeThe University of ToledoToledoUSA

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