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Application of the 3Rs Principles in the Development of Pharmaceutical Generics

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2021

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Vichare, Abhijit S.
Kamath, Sushant U.
Hayes, A. Wallace
Mahadevan, Brinda

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Regulatory Toxicology and Pharmacology : RTP. Elsevier. 2021, 125, 105016. ISSN 0273-2300. eISSN 1096-0295. Available under: doi: 10.1016/j.yrtph.2021.105016

Zusammenfassung

Although the 3Rs are broadly applied in nonclinical testing, a better appreciation of the 3Rs is needed in the field of differentiated or value-added pharmaceutical generics because the minor changes in formulation, dosage form, indication, and application route often do not require additional safety testing. The US FDA and the EU EMA have comprehensive regulations for such drugs based on quality, therapeutic equivalence, and safety guidelines. However, no scientific publications on how the concept of replacement and reduction from 3Rs principles can be applied in the safety assessment of differentiated generics were found in the public domain. In this review, we discuss the application of 3Rs in nonclinical testing requirements for differentiated generics. Practical examples are provided in the form of case studies from regulated markets. We highlight the need to utilize existing data to establish equivalence (differentiated generic vs innovator) in efficacy and safety. The case studies indicate that data requirements from animal experiments have been reduced to a large extent in some major markets without compromising quality and safety. In this context, we also highlight the problem that on a global scale, a true reduction of animal experiments will only be achieved when all countries adopt similar practices.

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570 Biowissenschaften, Biologie

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Generic drug, Animal, Toxicity, Impurities, Regulatory, Safety

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ISO 690VICHARE, Abhijit S., Sushant U. KAMATH, Marcel LEIST, A. Wallace HAYES, Brinda MAHADEVAN, 2021. Application of the 3Rs Principles in the Development of Pharmaceutical Generics. In: Regulatory Toxicology and Pharmacology : RTP. Elsevier. 2021, 125, 105016. ISSN 0273-2300. eISSN 1096-0295. Available under: doi: 10.1016/j.yrtph.2021.105016
BibTex
@article{Vichare2021-10Appli-54418,
  year={2021},
  doi={10.1016/j.yrtph.2021.105016},
  title={Application of the 3Rs Principles in the Development of Pharmaceutical Generics},
  volume={125},
  issn={0273-2300},
  journal={Regulatory Toxicology and Pharmacology : RTP},
  author={Vichare, Abhijit S. and Kamath, Sushant U. and Leist, Marcel and Hayes, A. Wallace and Mahadevan, Brinda},
  note={Article Number: 105016}
}
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