EurekaMag
+ Most Popular
Cunninghamia lanceolata plantations in China
Mammalian lairs in paleo ecological studies and palynology
Studies on technological possibilities in utilization of anhydrous milk fat for production of recombined butter-like products
Should right-sided fibroelastomas be operated upon?
Large esophageal lipoma
Apoptosis in the mammalian thymus during normal histogenesis and under various in vitro and in vivo experimental conditions
Poissons characoides nouveaux ou non signales de l'Ilha do Bananal, Bresil
Desensitizing efficacy of Colgate Sensitive Maximum Strength and Fresh Mint Sensodyne dentifrices
Administration of fluid by subcutaneous infusion: revival of a forgotten method
Tundra mosquito control - an impossible dream?
Schizophrenia for primary care providers: how to contribute to the care of a vulnerable patient population
Geochemical pattern analysis; method of describing the Southeastern limestone regional aquifer system
Incidence of low birth weights in a hospital of Mexico City
Tabanidae
Graded management intensity of grassland systems for enhancing floristic diversity
Microbiology and biochemistry of cheese and fermented milk
The ember tetra: a new pygmy characid tetra from the Rio das Mortes, Brazil, Hyphessobrycon amandae sp. n. (Pisces, Characoidei)
Risk factors of contrast-induced nephropathy in patients after coronary artery intervention
Renovation of onsite domestic wastewater in a poorly drained soil
Observations of the propagation velocity and formation mechanism of burst fractures caused by gunshot
Systolic blood pressure in a population of infants in the first year of life: the Brompton study
Haematological studies in rats fed with metanil yellow
Studies on pasteurellosis. I. A new species of Pasteurella encountered in chronic fowl cholera
Dormancy breaking and germination of Acacia salicina Lindl. seeds
therapy of lupus nephritis. a two-year prospective study

Robustness index score: a new stability parameter for designing robustness into biologic formulations


Robustness index score: a new stability parameter for designing robustness into biologic formulations



Journal of Pharmaceutical Sciences 101(2): 485-492



ISSN/ISBN: 0022-3549

PMID: 21976016

DOI: 10.1002/jps.22776

Formulation robustness is critical to product quality. A challenge in designing robustness into biologic formulations is the absence of one global parameter, which allows equitable comparison across formulations and quality measures. The new measure introduced here derived from accelerated testing data allows for the design of globally optimal robust formulations. The measure is easy to understand and also numerically and computationally stable when performing optimizations. The measure termed here as robustness index (RobX) score is a relative measure allowing for global optimization across multiple critical quality attributes. Described here are the calculation methods, a discussion of the measure characteristics, and a brief example of using RobX to find a global optimal formulation across multiple quality characteristics within the framework of a mixture experimental design. The data presented are actual stability data generated during a formulation experimental design for a monoclonal antibody. We anticipate this approach will provide a good general measure of drug stability and will help to accelerate the drug development process. We believe it will improve formulation robustness, long-term stability, and the delivery of quality drug products to the patient.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 055595038

Download citation: RISBibTeXText

Related references

A Unifying Mathematical Framework for Genetic Robustness, Environmental Robustness, Network Robustness and their Tradeoff on Phenotype Robustness in Biological Networks Part II: Ecological Networks. Evolutionary Bioinformatics Online 9: 69-85, 2013

A Unifying Mathematical Framework for Genetic Robustness, Environmental Robustness, Network Robustness and their Trade-off on Phenotype Robustness in Biological Networks Part I: Gene Regulatory Networks in Systems and Evolutionary Biology. Evolutionary Bioinformatics Online 9: 43-68, 2013

A Unifying Mathematical Framework for Genetic Robustness, Environmental Robustness, Network Robustness and their Trade-offs on Phenotype Robustness in Biological Networks. Part III: Synthetic Gene Networks in Synthetic Biology. Evolutionary Bioinformatics Online 9: 87-109, 2013

Artifact robustness, inter- and intraindividual baseline stability, and rational EEG parameter selection. Anesthesiology 96(1): 54-59, 2002

Stability robustness of discrete-time singular systems with structured parameter perturbations. Journal of Dynamic Systems, Measurement, and Control 121(3): 547-549, 1999

Service-level performance of MRP, kanban, CONWIP and DBR due to parameter stability and environmental robustness. International Journal of Production Research 46(8): 2179-2195, 2008

Stability robustness of singular systems with time-varying structured parameter uncertainties. Jsme International Journal. Series C, Mechanical Systems, Machine Elements and Manufacturing 44(1): 114-117, 2001

Stability robustness analysis of discrete-time systems with multiple large parameter variations. Automatica 30(2): 357-361, 1994

Asymmetric sufficient condition for stability robustness of singular systems with structured parameter uncertainties. Journal of Mathematical Analysis and Applications 258(1): 171-182, 2001

Room E, 10/16/2000 9: 00 AM - 11: 00 AM (PS) Artifact Robustness, Inter-/Intraindividual Baseline Stability and Rational EEG Parameter Selection. Anesthesiology 93(Suppl): A-264, 2000

Stability robustness of LQ optimal regulators for the performance index with cross-product terms. IEEE Transactions on Automatic Control 39(8): 1698-1702, 1994

Opercular Index Score: a CT angiography-based predictor of capillary robustness and neurological outcomes in the endovascular management of acute ischemic stroke. Journal of Neurointerventional Surgery 9(12): 1179-1186, 2017

Is robustness really robust? How different definitions of robustness impact decision-making under climate change. Climatic Change 135(3-4): 409-424, 2016

Defining robustness protocols: a method to include and evaluate robustness in clinical plans. Physics in Medicine and Biology 60(7): 2671-2684, 2015

Robustness of Results and Robustness of Derivations: The Internal Architecture of a Solid Experimental Proof. Boston Studies in the Philosophy of Science 292: 227-266, 2012