Introduction to the OrBiTo decision tree to select the most appropriate in vitro methodology for release testing of solid oral dosage forms during development. Andreas, C. J., Rosenberger, J., Butler, J., Augustijns, P., McAllister, M., Abrahamsson, B., & Dressman, J. Eur J Pharm Biopharm, 130:207–213, September, 2018.
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The EU research initiative OrBiTo (oral biopharmaceutics tools) involving partners from academia, pharmaceutical industry, small medium enterprises and a regulatory agency was launched with the goal of improving tools to predict the absorption of drugs in humans and thereby accelerating the formulation development process. The OrBiTo project was divided into four work packages (WP), with WP2 focusing on characterization of drug formulations. The present work introduces the OrBiTo WP2 Decision Tree, which is designed to assist the investigator in choosing the most appropriate in vitro methods for optimizing the oral formulation design and development process. The WP2 Decision Tree consists of four stages to guide the investigator. At the first stage, the investigator is asked to choose the formulation type of interest. At the second stage, the investigator is asked to identify which type of equipment (compendial/modified/noncompendial) is preferred/available. At the third stage, characteristics of the active pharmaceutical ingredient (API) are evaluated and in the fourth stage of the decision tree, suitable experimental protocols are recommended. A link to the living Decision Tree document is provided, and we now invite the pharmaceutical sciences community to apply it to current research and development projects and offer suggestions for improvement and expansion.
@article{andreas_introduction_2018,
	title = {Introduction to the {OrBiTo} decision tree to select the most appropriate in vitro methodology for release testing of solid oral dosage forms during development},
	volume = {130},
	issn = {1873-3441 (Electronic) 0939-6411 (Linking)},
	doi = {10.1016/j.ejpb.2018.07.003},
	abstract = {The EU research initiative OrBiTo (oral biopharmaceutics tools) involving partners from academia, pharmaceutical industry, small medium enterprises and a regulatory agency was launched with the goal of improving tools to predict the absorption of drugs in humans and thereby accelerating the formulation development process. The OrBiTo project was divided into four work packages (WP), with WP2 focusing on characterization of drug formulations. The present work introduces the OrBiTo WP2 Decision Tree, which is designed to assist the investigator in choosing the most appropriate in vitro methods for optimizing the oral formulation design and development process. The WP2 Decision Tree consists of four stages to guide the investigator. At the first stage, the investigator is asked to choose the formulation type of interest. At the second stage, the investigator is asked to identify which type of equipment (compendial/modified/noncompendial) is preferred/available. At the third stage, characteristics of the active pharmaceutical ingredient (API) are evaluated and in the fourth stage of the decision tree, suitable experimental protocols are recommended. A link to the living Decision Tree document is provided, and we now invite the pharmaceutical sciences community to apply it to current research and development projects and offer suggestions for improvement and expansion.},
	journal = {Eur J Pharm Biopharm},
	author = {Andreas, C. J. and Rosenberger, J. and Butler, J. and Augustijns, P. and McAllister, M. and Abrahamsson, B. and Dressman, J.},
	month = sep,
	year = {2018},
	keywords = {*Decision Trees, Administration, Oral, Biopharmaceutics classification system (BCS), Biopharmaceutics/*methods, Decision tree, Dissolution, Drug Design, Drug Industry/methods, Drug Liberation, Formulation, Humans, Oral absorption, Pbpk, Pharmaceutical Preparations/*administration \& dosage/metabolism},
	pages = {207--213},
}

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