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A Sponsor's Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan.

Autor: Wolter KD; Pfizer, Groton, CT, USA., Kamatani A; Pfizer, Tokyo, Japan., Suzuki Y; Pfizer, Tokyo, Japan., Imaeda T; Pfizer, Tokyo, Japan., Dagher R; Pfizer, Groton, CT, USA., Safferman A; Pfizer, Groton, CT, USA., Junor R; Pfizer R&D UK Limited, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Rod.Junor@Pfizer.com.

Publikováno v: Pharmaceutical medicine [Pharmaceut Med] 2024 May; Vol. 38 (3), pp. 217-224. Date of Electronic Publication: 2024 Mar 31.

Efficacy and safety of equine anti-thymocyte immunoglobulin (eATG) in three Japanese patients with moderate to very severe aplastic anemia: a case series.

Autor: Kanda Y; Division of Hematology, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke-Shi, Tochigi-Ken, 329-0498, Japan. ycanda-tky@umin.ac.jp., Mori T; Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.; Department of Hematology, Tokyo Medical and Dental University, Tokyo, Japan., Narita A; Department of Pediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan., Wolter KD; Pfizer Inc, New York, NY, USA., Yoshimatsu H; Pfizer R&D Japan, Tokyo, Japan., Nishimura K; Pfizer R&D Japan, Tokyo, Japan.

Publikováno v: International journal of hematology [Int J Hematol] 2023 Jan; Vol. 117 (1), pp. 37-43. Date of Electronic Publication: 2022 Nov 28.

A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer.

Autor: Hartman LR; Children's Hospital Colorado, Aurora, Colorado, USA., Nurmeev I; Kazan State Medical University, Kazan, Russia., Svirin P; Municipal Center of Hemophilia Therapy for Children and Adolescents, Municipal Health Children's Hospital Morozovskaya, Moscow, Russia., Wolter KD; Pfizer Inc, New York, New York, USA., Yan JL; Agenus Bio, Lexington, Massachusetts, USA., Jani D; Pfizer Inc, New York, New York, USA., Goldenberg NA; Departments of Pediatrics and Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Johns Hopkins All Children's Cancer and Blood Disorders Institute, Heart Institute, and Institute for Clinical and Translational Research, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA., Sherman N; Pfizer Inc, New York, New York, USA.

Publikováno v: Pediatric blood & cancer [Pediatr Blood Cancer] 2022 Aug; Vol. 69 (8), pp. e29764. Date of Electronic Publication: 2022 Jun 09.

Clinical cure rates in subjects treated with azithromycin for community-acquired respiratory tract infections caused by azithromycin-susceptible or azithromycin-resistant Streptococcus pneumoniae: analysis of Phase 3 clinical trial data.

Autor: Zhanel GG; Department of Medical Microbiology and Infectious Diseases, Faculty of Medicine, University of Manitoba, Winnipeg, Canada ggzhanel@pcs.mb.ca., Wolter KD; Established Products Clinical Development, Pfizer Inc., New York, NY, USA., Calciu C; Medical Affairs, Pfizer Canada Inc., Montreal, Canada., Hogan P; Specialty Care Business Unit, Pfizer Inc., New York, NY, USA., Low DE; Department of Microbiology, Mount Sinai Hospital, Toronto, Canada., Weiss K; Maisonneuve-Rosemont Hospital, Faculty of Medicine, University of Montreal, Montreal, Canada., Karlowsky JA; Department of Medical Microbiology and Infectious Diseases, Faculty of Medicine, University of Manitoba, Winnipeg, Canada.

Publikováno v: The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2014 Oct; Vol. 69 (10), pp. 2835-40. Date of Electronic Publication: 2014 Jun 11.