Development and validation of a Level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology.

Autor: Kushner J 4th; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: joseph.kushner@pfizer.com., Lamba M; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: lamba.manisha@gmail.com., Stock T; Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: doctcs2@gmail.com., Wang R; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: rong.wang2@pfizer.com., Nemeth MA; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: maryanne.nemeth@pfizer.com., Alvey C; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: cwalvey@comcast.net., Chen R; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: raymond.chen@pfizer.com., DeMatteo V; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: vincent.dematteo@pfizer.com., Blanchard A; Pfizer Inc, 558 Eastern Point Rd, Groton, CT 06340, USA. Electronic address: andrew.blanchard@pfizer.com.

Publikováno v: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2020 Apr 30; Vol. 147, pp. 105200. Date of Electronic Publication: 2019 Dec 19.

Extended-Release Once-Daily Formulation of Tofacitinib: Evaluation of Pharmacokinetics Compared With Immediate-Release Tofacitinib and Impact of Food.

Autor: Lamba M; Pfizer Inc, Groton, CT, USA. Manisha.lamba@pfizer.com., Wang R; Pfizer Inc, Groton, CT, USA., Fletcher T; Pfizer Inc, Collegeville, PA, USA., Alvey C; Pfizer Inc, Groton, CT, USA., Kushner J 4th; Pfizer Inc, Groton, CT, USA., Stock TC; Pfizer Inc, Collegeville, PA, USA.

Publikováno v: Journal of clinical pharmacology [J Clin Pharmacol] 2016 Nov; Vol. 56 (11), pp. 1362-1371.

Utilizing quantitative certificate of analysis data to assess the amount of excipient lot-to-lot variability sampled during drug product development.

Autor: Kushner J 4th; Pfizer Worldwide Research and Development, Groton, CT 06340, USA. joseph.kushner@pfizer.com

Publikováno v: Pharmaceutical development and technology [Pharm Dev Technol] 2013 Mar-Apr; Vol. 18 (2), pp. 333-42. Date of Electronic Publication: 2011 Aug 30.

Examining the impact of excipient material property variation on drug product quality attributes: a quality-by-design study for a roller compacted, immediate release tablet.

Autor: Kushner J 4th; Pfizer Global Research and Development, Groton, Connecticut 06340, USA. joseph.kushner@pfizer.com, Langdon BA, Hiller JI, Carlson GT

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2011 Jun; Vol. 100 (6), pp. 2222-39. Date of Electronic Publication: 2011 Feb 11.

Scale-up model describing the impact of lubrication on tablet tensile strength.

Autor: Kushner J 4th; Pharmaceutical Development, Pfizer Global Research and Development, Groton, CT 06340, USA. joseph.kushner@pfizer.com, Moore F

Publikováno v: International journal of pharmaceutics [Int J Pharm] 2010 Oct 31; Vol. 399 (1-2), pp. 19-30. Date of Electronic Publication: 2010 Aug 03.