The impact of quality culture on operational performance—an empirical study from the pharmaceutical industry
…, P Buess, S Köhler, C Chen, S Mendivil… - PDA journal of …, 2018 - journal.pda.org
Quality culture as an enabler of high-quality performance and subsequently as a source of
competitive advantage is increasingly discussed among operational excellence (OPEX) and …
competitive advantage is increasingly discussed among operational excellence (OPEX) and …
[PDF][PDF] Quality by design: Current regulatory status and future challenges
S Mendivil, A Burns - BioProcess International, 2009 - eu-assets.contentstack.com
BioProcess International 85 SUPPLEMENT hand the full-scale process over to the production
facility. Often, there is inefficient interaction between the personnel that develop and scale-…
facility. Often, there is inefficient interaction between the personnel that develop and scale-…
Parenteral drug association points to consider: pharmaceutical quality metrics updated September 2014
PDA June, S Mendivil, J Bloomfield… - PDA Journal of …, 2014 - journal.pda.org
1.1 Background The 2012 Food Drug Administration Safety and Innovation Act (FDASIA)
gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and …
gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and …
[HTML][HTML] How to Measure Quality Management Maturity
D Baker, J Broadfoot, S Mendivil, A Caruso, S Lueken - 2021 - pda.org
Background PDA published its “Quality Culture Survey Report” in the PDA JPST in 2015 (1)
and presented the findings at the “Joint PDA FDA Quality Metrics Conference” that same year…
and presented the findings at the “Joint PDA FDA Quality Metrics Conference” that same year…
[PDF][PDF] Results of a survey of biological drug and device industries inspected by FDA under the Team Biologics Program
…, VJ Gangi, A Johnson, J Little, S Mendivil… - PDA Journal of …, 2007 - pqri.org
The Product Quality Research Institute, in conjunction with the Food and Drug Administration,
conducted an anonymous, electronic survey of the biological products manufacturing …
conducted an anonymous, electronic survey of the biological products manufacturing …
FDA Quality Metrics-Marci Goldfinger & Anne Pericone Johnson & Johnson
A Pericone - 2018 - policycommons.net
This presentation provides an overview of the evolution of these guidance documents, along
with a review of the data elements in the most recent draft guidance and the metrics FDA …
with a review of the data elements in the most recent draft guidance and the metrics FDA …
Computing the monge–kantorovich distance
F Mendivil - Computational and Applied Mathematics, 2017 - Springer
The Monge–Kantorovich distance gives a metric between probability distributions on a
metric space $${\mathbb X}$$ X and the MK distance is tied to the underlying metric on $${\…
metric space $${\mathbb X}$$ X and the MK distance is tied to the underlying metric on $${\…
AMG 479, a novel IGF-1-R antibody, inhibits endometrial cancer cell proliferation through disruption of the PI3K/Akt and MAPK pathways
A Mendivil, C Zhou, LA Cantrell… - Reproductive …, 2011 - journals.sagepub.com
Our goal was to evaluate the therapeutic potential of a novel antibody to the insulin growth
factor-1 receptor (IGF-1-R; AMG 479) in endometrial cancer cells. The endometrial cancer cell …
factor-1 receptor (IGF-1-R; AMG 479) in endometrial cancer cells. The endometrial cancer cell …
Durvalumab, with or without tremelimumab, plus platinum–etoposide versus platinum–etoposide alone in first-line treatment of extensive-stage small-cell lung cancer …
…, DI Casado, MD Gomez, AN Mendivil… - The Lancet …, 2021 - thelancet.com
Background First-line durvalumab plus etoposide with either cisplatin or carboplatin (platinum–etoposide)
showed a significant improvement in overall survival versus platinum–…
showed a significant improvement in overall survival versus platinum–…
[CITATION][C] The UC Small Farm Program
…, L Greensfelder, P Ilic, M Jimenez, S Mendivil… - UC Small Farm Program …, 1990