[HTML][HTML] Ex vivo fludarabine exposure inhibits graft-versus-host activity of allogeneic T cells while preserving graft-versus-leukemia effects
CR Giver, RO Montes, S Mittelstaedt, JM Li… - Biology of Blood and …, 2003 - Elsevier
Allogeneic donor T cells in bone marrow transplantation (BMT) can contribute to beneficial
graft-versus-leukemia (GVL) effects but can also cause detrimental graft-versus-host disease (…
graft-versus-leukemia (GVL) effects but can also cause detrimental graft-versus-host disease (…
Simple approach to calculate random effects model tolerance intervals to set release and shelf-life specification limits of pharmaceutical products
RO Montes, RK Burdick, DJ Leblond - PDA Journal of …, 2019 - journal.pda.org
Tolerance intervals are used to statistically derive the acceptance limits to which drugs must
conform upon manufacture (release) and throughout shelf-life. The single measurement per …
conform upon manufacture (release) and throughout shelf-life. The single measurement per …
Frequentist and Bayesian tolerance intervals for setting specification limits for left‐censored gamma distributed drug quality attributes
RO Montes - Pharmaceutical Statistics, 2024 - Wiley Online Library
Tolerance intervals from quality attribute measurements are used to establish specification
limits for drug products. Some attribute measurements may be below the reporting limits, that …
limits for drug products. Some attribute measurements may be below the reporting limits, that …
Statistical considerations for demonstration of analytical similarity
H Yang, RK Burdick, A Cheng, RO Montes - … : Regulatory, Clinical, and …, 2018 - Springer
Analytical similarity is the foundation for demonstration of biosimilarity between a proposed
biosimilar product and a reference product. For this assessment, the FDA has recommended …
biosimilar product and a reference product. For this assessment, the FDA has recommended …
Variation transmission model for setting acceptance criteria in a multi-staged pharmaceutical manufacturing process
RO Montes - AAPS PharmSciTech, 2012 - Springer
Pharmaceutical manufacturing processes consist of a series of stages (eg, reaction, workup,
isolation) to generate the active pharmaceutical ingredient (API). Outputs at intermediate …
isolation) to generate the active pharmaceutical ingredient (API). Outputs at intermediate …
[HTML][HTML] The astropy project: sustaining and growing a community-oriented open-source project and the latest major release (v5. 0) of the core package
…, TL Aldcroft, JA Alvarado-Montes… - The Astrophysical …, 2022 - iopscience.iop.org
The Python programming language is a high-level, interpreted (as opposed to compiled)
programming language that has become an industry standard across many computational …
programming language that has become an industry standard across many computational …
[PDF][PDF] Simple Approach to Calculate Random Effects Model
RO Montes, RK Burdick, DJ Leblond - researchgate.net
Tolerance intervals are used to statistically derive the acceptance limits to which drugs must
conform upon manufacture (release) and throughout shelf-life. The single measurement per …
conform upon manufacture (release) and throughout shelf-life. The single measurement per …
[PDF][PDF] Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release Limits and Shelf-life Specification Limits of Pharmaceutical Products
RO Montes, RK Burdick, DJ LeBlond - 2018 - asa-qprc.org
• A specification is defined as a list of tests, references to analytical procedures, and
appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests …
appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests …
[BOOK][B] Physicochemical modulation of sickle adherence: A different in vitro model
RAO Montes - 1999 - search.proquest.com
Previous adhesion models have attributed sickle adhesivity mostly to the presence of highly
specific cell adhesion molecules associated with acute events like endothelial perturbation, …
specific cell adhesion molecules associated with acute events like endothelial perturbation, …
[HTML][HTML] Improved Survival in Patients with Refractory Cytopenias (Low Risk Myelodysplastic Syndrome-MDS) Treated with Allogeneic T-Cell Depleted Hematopoietic …
…, MA Perales, M Maloy, C Montes-Gaisan, RJ O'Reilly… - Blood, 2011 - Elsevier
Abstract 3831 Background: Controversy exists regarding optimal treatment for pts with MDS
with low blast percentages. Benefits of early transplant versus transplant-related morbidity …
with low blast percentages. Benefits of early transplant versus transplant-related morbidity …