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Design of Clinical Formulations in Early Development

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Book cover Translating Molecules into Medicines

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 25))

Abstract

Thoughtfully designed early clinical formulations not only meet the needs of the study at hand and inform the development of the commercial product, but can influence the direction of the clinical program as well as provide further guidance to potential backups still in exploratory stages. This chapter focuses on the various types of early clinical formulations, why they are developed, and how the preclinical formulation space helps to guide initial clinical formulation selection. Impacts on clinical program development will be presented through case studies and examples in context of the types of clinical studies being supported: what is the goal of the clinical study, what questions need to be answered, and how will the information be used in subsequent development? Additional factors influencing formulation selection such as patient needs, the practicality of switching between dosage forms, and commercialization potential will be reviewed.

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Author information

Authors and Affiliations

  1. Drug Product Design, Pfizer Inc., Groton, CT, USA

    Catherine M. Ambler & Avinash G. Thombre

  2. Drug Product Science & Technology, Bristol-Myers Squibb Co., New Brunswick, NJ, USA

    Madhushree Gokhale

  3. Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Wallingford, CT, USA

    John S. Morrison

Authors
  1. Catherine M. Ambler
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  2. Avinash G. Thombre
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  3. Madhushree Gokhale
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  4. John S. Morrison
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Corresponding author

Correspondence to Catherine M. Ambler .

Editor information

Editors and Affiliations

  1. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    Shobha N. Bhattachar

  2. Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Wallingford, Connecticut, USA

    John S. Morrison

  3. ADME, Drug Disposition, Eli Lilly and Company, Indianapolis, Indiana, USA

    Daniel R. Mudra

  4. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    David M. Bender

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© 2017 American Association of Pharmaceutical Scientists

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Ambler, C.M., Thombre, A.G., Gokhale, M., Morrison, J.S. (2017). Design of Clinical Formulations in Early Development. In: Bhattachar, S., Morrison, J., Mudra, D., Bender, D. (eds) Translating Molecules into Medicines. AAPS Advances in the Pharmaceutical Sciences Series, vol 25. Springer, Cham. https://doi.org/10.1007/978-3-319-50042-3_10

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