As the indications of Tasigna® and Glivec® overlap for the majority of patients but are not identical, a marketing authorization for Imatinib generics restricted to the indications not granted for Tasigna® became possible. This is why the indications of generic Imatinib products are different from the indications of the reference AZD5582 in vitro product Glivec®. Conclusion A decade ago, TKI were introduced into clinical

Selleck PI3K Inhibitor Library anti-cancer therapy. At first sight, the molecular mechanism of action appears to comprise only a targeted approach in blocking tyrosine kinases. However, this should not be misleading; numerous closely interconnected signaling pathways are involved and the complexity of TKI molecular mechanism is far from

being understood completely. For clinicians, TKI are a worthy new modality of tumor-therapy amending classical cytotoxic regimes. TKI are of substantial benefit in terms of efficacy with a tolerable safety profile. However, long-term safety issues might not be fully elucidated at present and, thus, cannot be finally judged upon. Throughout the next years, many of these substances will run off-patent. Thus, regulatory guidance will be required for instance on whether certain substances like Sunitinib fulfill the criteria of a narrow therapeutic index drug. Apart from that, most TKI are orally administered, thereby raising the question whether BCS-based biowaiver click here can apply. In addition, design and requirements of BE-studies will be an issue in the EMA-initiative of product specific guidance on anti-cancer-TKI. Disclaimer The opinions mentioned throughout the following article are personal views of the authors and do not reflect an official position of the Federal Institute of Drugs and Medical Devices or an EMA-committee or working party, respectively. Funding The support of Andreas Duda is gratefully acknowledged. Gemcitabine solubility dmso This systematic review article was supported by intramural funding of the Federal Institute for Drugs and Medical Devices (BfArM). References

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