editedbook
Publication: IIP Proceedings Year: 2022, Month: November Page No: 197-213, ISSN/ISBN: 978-93-95632-88-1, DOI/Link: https://rsquarel.org/assets/docupload/rsl2023D537468E5C4ABFA.pdf
DEVELOPING INTEGRATED PHARMACOKINETICS AND BIOSEPARATION METHODS FOR DRUG DISCOVERY
Area/Stream: Biotechnology, Authors: Haragouri Mishra, Abinash Patra, Shyama Sundar Sahu, Amulyaratna Behera, Rabisankar Dash Keywords: Therapeutic Delivery System, Bioanalytical methods, Endogenous substances, Bioequivalence, Drug Discovery Book Name /series: Futuristic Trends in Biotechnology ,Volume 2, Book 27, Part 2, Chapter 4Publication: IIP Proceedings Year: 2022, Month: November Page No: 197-213, ISSN/ISBN: 978-93-95632-88-1, DOI/Link: https://rsquarel.org/assets/docupload/rsl2023D537468E5C4ABFA.pdf
Abstract:
The advancement of pharmacokinetics has allowed this science to take the lead in the discovery of novel bioactive molecules for clinical use, resulting in a wide range of offpatent drug formulations such as prolonged and delayed release, therapeutic delivery systems, and so on (TDS). Orally disintegrating and effervescent preparations, intramuscular and subcutaneous depot formulations are used to permit drugs to circulate systemically, eradicating the first pass effect. Bioanalytical approaches were necessary for measuring drug concentrations, even at the plasma level, in the aforementioned applications that mirrored the development of pharmacokinetics in a synergistic manner. In response to the intricacy of the aforementioned realisations, the US FDA and EU EMA have produced guidelines, and the majority of the aforementioned applications have been streamlined and standardised to include waivers of in vivo bioequivalence. However, there are a number of points that must be explained by regulators but are not yet addressed in operational standards. Concerning the planning and execution of bioavailability and bioequivalence tests with endogenous compounds, there is an essential issue. Particularly relevant are endogenous chemicals, such as melatonin and female sex hormones, because they have their own homeostatic balance with fluctuations. In most circumstances, quantifying the net contribution of the exogenous drug to the exogenously absorbed drug based on the needed baseline subtraction is not simple.
Cite this: Haragouri Mishra, Abinash Patra, Shyama Sundar Sahu, Amulyaratna Behera, Rabisankar Dash,"DEVELOPING INTEGRATED PHARMACOKINETICS AND BIOSEPARATION METHODS FOR DRUG DISCOVERY", Futuristic Trends in Biotechnology ,Volume 2, Book 27, Part 2, Chapter 4, November, 2022, 197-213, 978-93-95632-88-1, https://rsquarel.org/assets/docupload/rsl2023D537468E5C4ABFA.pdf
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