Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting

Therapeutic Innovation & Regulatory Science, vol. 58, pp. 423–430

Authors 10

1. Annett Keller corresponding

   Boehringer Ingelheim (Germany)

   Affiliation as printed

   Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH &Co. KG, Binger Strasse 173, 55216, Ingelheim, Germany. annett.keller@boehringer-ingelheim.com

   Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH &Co. KG, Binger Strasse 173, 55216, Ingelheim, Germany

2. Nathalie van Borrendam Aachen Integrated Data Analytics and Reporting

   Janssen (Netherlands)

   Affiliation as printed

   Integrated Data Analytics and Reporting, Janssen Research and Development, Graaf Engelbertlaan 75, 4837DS, Breda, Netherlands

3. Patrice Benner

   Merck & Co., Inc., Rahway, NJ, USA (United States)

   Affiliation as printed

   Global Data Management and Standards, Merck & Co., Inc, 770 Sumneytown Pike, West Point, PA, 19486, USA

4. Steven A. Gilbert

   Pfizer (United States)

   Affiliation as printed

   Statistical Research and Innovation, Pfizer, 100 Cambridge Park Drive, Cambridge, MA, 02140, USA

5. Stefano Saino

   MSD (Italy)

   Affiliation as printed

   Risk Evaluation and Adaptive Integrated Monitoring, MSD, V. F.lli Cervi, Palazzo Canova, 20090, Segrate, Milan, Italy

6. Debra Jendrasek

   Daiichi Sankyo (United States)

   Affiliation as printed

   Risk Based Quality Management, Daiichi Sankyo, 211 Mount Airy Rd, Basking Ridge, NJ, 07920, USA

7. Marcus Muli

   Merck & Co., Inc., Rahway, NJ, USA (United States)

   Affiliation as printed

   Biostatistics and Research Decision Sciences, Merck & Co., Inc, 351 N. Sumneytown Pike, North Wales, PA, 19454, USA

8. Jim Jian Wang

   Janssen (United States) · Janssen Research & Development (United States)

   Affiliation as printed

   Statistics & Decision Sciences, Janssen Research and Development, 920 Route 202, Raritan, NJ, 08869, USA

9. Marta Kozińska

   AstraZeneca (Poland)

   Affiliation as printed

   Centralized Monitoring, BioPharmaceuticals Clinical Operations, R&D, AstraZeneca, Postepu 14, 02-676, Warsaw, Poland

10. Jun S. Liu

    Astellas Pharma (United States)

    Affiliation as printed

    Centralized Monitoring, Astellas, 1 Astellas Way, Northbrook, IL, 60062, USA