Framework for sensitization assessment of extractables and leachables in pharmaceuticals

Author:

Parris Patricia1,Whelan Geraldine2,Burild Anders3,Whritenour Jessica4,Bruen Uma5,Bercu Joel6,Callis Courtney7,Graham Jessica8,Johann Esther9,Griffin Troy10,Kohan Martin11,Martin Elizabeth A.11,Masuda-Herrera Melisa6,Stanard Brad12,Tien Eric13,Cruz Maureen14,Nagao Lee14

Affiliation:

1. Pfizer Worldwide Research, Development and Medical, Kent, UK

2. GlaxoSmithKline, Ware, UK

3. Novo Nordisk A/S, Safety Sciences, Imaging and Data Management, Måløv, Denmark

4. Pfizer Worldwide Research, Development and Medical, Groton, CT, USA

5. Organon USA Inc., Jersey City, NJ, USA

6. Gilead Sciences Inc., Foster City, CA, USA

7. Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN, USA

8. Genentech, Inc., South San Francisco, CA, USA

9. Merck KGaA, Darmstadt, Germany

10. Teva Branded Pharmaceutical Products R&D, West Chester, PA, USA

11. Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK

12. Ultragenyx Pharmaceutical Inc., Novato, CA, USA

13. Biogen, Inc., Cambridge, MA, USA

14. Faegre Drinker Biddle & Reath LLP, Washington, DC, USA

Publisher

Informa UK Limited

Subject

Toxicology

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