Pharmaceutics and Novel Drug Delivery Systems

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Long-acting therapies always attract many scientists attentions and they are also the most important drug research and development areas as well. For example, especially in diabetic and oncology fields etc. long-acting medicines will play an important role on all aspects of improving the diseases and reducing patient’s sufferings. However, challenge in bioanalytical methodologies for such specially formulated drugs are significant, especially for determination of concentrations of the drugs, and as well as their metabolites in plasma, serum or tissue. Therefore, development of a reliable bioanalytical method will be extremely important for the pharmacokinetic/pharmacodynamic (PK/PD) clinical studies and for pre-clinical studies in the drug development processes. In this presentation, the bioanalytical methods developed in our laboratories and their related results for long-acting insulin analogue-glargine (Lantus) and liposomes formatted doxorubicin will be introduced. Especially when high sensitivity LC-MS/MS systems are used in the methods, the challenges in biofluid extraction procedures, HPLC conditions, and as well as parameters for mass spectrometry are discussed as examples. For such successfully developed and validated methods following US FDA and European EMA guidance, they are successfully used in clinical trial studies for their PK/PD assessments.

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With Regards,
Drug Designing: Open Access
Editorial Manager
Email: drugdesign@longdom.org
Whats App:+1-947-333-4405.