Search Results - "Manser, Kimberly"

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    Physicochemical properties, form, and formulation selection strategy for a biopharmaceutical classification system class II preclinical drug candidate by Lohani, Sachin, Cooper, Harriet, Jin, Xiaoling, Nissley, Becky P, Manser, Kimberly, Rakes, Linda Huong, Cummings, John J, Fauty, Scott E, Bak, Annette

    Published in Journal of pharmaceutical sciences (01-10-2014)
    “…This work summarizes the pharmaceutical evaluation of a preclinical drug candidate with poor physicochemical properties. Compound 1 is a weakly basic, GPR-119…”
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    Utility of PBPK Absorption Modeling to Guide Modified Release Formulation Development of Gaboxadol, a Highly Soluble Compound With Region-Dependent Absorption by Kesisoglou, Filippos, Balakrishnan, Anand, Manser, Kimberly

    Published in Journal of pharmaceutical sciences (01-02-2016)
    “…Given the complexity of controlled release (CR) formulations, selecting the right preclinical tools is important to enable decision making on the in vivo…”
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  4. 4

    Use of minipig skin biopsy model as an innovative tool to design topical formulation to achieve desired pharmacokinetics in humans by Mitra, Amitava, Leyes, Aquiles, Manser, Kimberly, Roadcap, Brad, Mestre, Christine, Tatosian, Daniel, Jin, Lan, Uemura, Naoto

    Published in Journal of pharmaceutical sciences (01-05-2015)
    “…In vitro cadaver skin permeation studies are often conducted to characterize the permeation profile of compounds for dermal delivery. However, its utility…”
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  5. 5

    Analysis of the absorption kinetics of macromolecules following intradermal and subcutaneous administration by Milewski, Mikolaj, Manser, Kimberly, Nissley, Becky P., Mitra, Amitava

    “…[Display omitted] •Human and minipig absorption rates of eight peptides and proteins were analyzed.•Simultaneous fits and numerical deconvolution methods were…”
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    Suitability of a minipig model in assessing clinical bioperformance of matrix and multiparticulate extended-release formulations for a BCS class III Drug development candidate by Kesisoglou, Filippos, Xie, Iris Huizhi, Manser, Kimberly, Wu, Yunhui, Hardy, Ian, Fitzpatrick, Shaun

    Published in Journal of pharmaceutical sciences (01-02-2014)
    “…Preclinical studies in dogs are often employed as part of formulation screening process. However, the shorter transit time and colonic length in dogs may…”
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  7. 7

    Application of in vitro transmucosal permeability, dose number, and maximum absorbable dose for biopharmaceutics assessment during early drug development for intraoral delivery by Yang, Zhen, Sotthivirat, Sutthilug, Wu, Yunhui, Lalloo, Anita, Nissley, Becky, Manser, Kimberly, Li, Hankun

    Published in International journal of pharmaceutics (30-04-2016)
    “…[Display omitted] Intraoral (IO) administration is a unique route that takes advantage of transmucosal absorption in the oral cavity to deliver a drug…”
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    Model-Based Decision Making in Early Clinical Development: Minimizing the Impact of a Blood Pressure Adverse Event by Stroh, Mark, Addy, Carol, Wu, Yunhui, Aubrey Stoch, S., Pourkavoos, Nazaneen, Groff, Michelle, Xu, Yang, Wagner, John, Gottesdiener, Keith, Shadle, Craig, Wang, Hong, Manser, Kimberly, Winchell, Gregory A., Stone, Julie A.

    Published in The AAPS journal (01-03-2009)
    “…We describe how modeling and simulation guided program decisions following a randomized placebo-controlled single-rising oral dose first-in-man trial of…”
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