Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)

Colerangle, John B.

doi:10.1016/b978-0-12-387815-1.00022-8

Cited by 3 publications

(1 citation statement)

References 15 publications

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“…In conventional pharmaceutical industry language, these formulations have come to be termed preclinical formulations (1,2). An example may be a simple suspension formulation of the NCE to be dosed via an oral gavage to mice for an efficacy study.…”

Section: Introductionmentioning

confidence: 99%

Preclinical Formulations: Insight, Strategies, and Practical Considerations

et al. 2014

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Abstract. A lot of resources and efforts have been directed to synthesizing potentially useful new chemical entities (NCEs) by pharmaceutical scientists globally. Detailed physicochemical characterization of NCEs in an industrial setup begins almost simultaneously with preclinical testing. Most NCEs possess poor water solubility posing bioavailability issues during initial preclinical screening, sometimes resulting in dropping out of an NCE with promising therapeutic activity. Selection of right formulation approach for an NCE, based on its physicochemical properties, can aid in improving its solubility-related absorption and bioavailability issues. The review focuses on preclinical formulations stressing upon different preclinical formulation strategies and deciphers the understanding of formulation approaches that could be employed. It also provides detailed information related to a vast pool of excipients available today, which is of immense help in designing preclinical formulations. Few examples mentioned, throw light on key aspects of preclinical formulation development. The review will serve as an important guide for selecting the right strategy to improve bioavailability of NCEs for academic as well as industrial formulation scientists.

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Section: Introductionmentioning

confidence: 99%