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https://www.readbyqxmd.com/read/29332630/effects-of-a-program-of-cognitive-behavioural-group-therapy-vestibular-rehabilitation-and-psychoeducational-explanations-on-patients-with-dizziness-and-no-quantified-balance-deficit-compared-to-patients-with-dizziness-and-a-quantified-balance-deficit
#1
D A Schmid, J H J Allum, M Sleptsova, S Gross, J Gaab, A Welge-Lüssen, R Schaefert, W Langewitz
BACKGROUND: We examined whether a program combining cognitive-behavioural therapy (CBT), vestibular rehabilitation (VR) and psychoeducation is equally effective in improving psychometric measures in patients with dizziness independent of a balance deficit. Measures of patients with dizziness only (DO) were compared to those of patients also having a quantified balance deficit (QBD). METHODS: 32 patients (23 female, 9 male) with persistent dizziness were analysed as 2 groups based on stance and gait balance control: those with QBD (pathological balance) or DO (normal balance)...
February 2018: Journal of Psychosomatic Research
https://www.readbyqxmd.com/read/29318320/optimization-of-uplc-method-for-simultaneous-determination-of-rosuvastatin-and-rosuvastatin-degradation-products
#2
Jure Zakrajšek, Katarina Bevc-Černilec, Simona Bohanec, Uroš Urleb
An ultra-performance liquid chromatographic method for simultaneous determination of rosuvastatin and rosuvastatin degradation products was developed and optimized by using fractional factorial experimental design. Optimized method is capable to accurately determine all potential degradation products of rosuvastatin. During the optimization the effect of four chosen chromatographic factors was evaluated. The analytical method operational design region was modeled using Umetrics MODDE software and optimal chromatographic conditions were predicted...
December 2017: Acta Chimica Slovenica
https://www.readbyqxmd.com/read/29306677/role-of-raw-materials-in-biopharmaceutical-manufacturing-risk-analysis-and-fingerprinting
#3
REVIEW
Anurag S Rathore, Deepak Kumar, Nikhil Kateja
Accurate fingerprinting of critical raw materials that have significant impact on process performance and product quality is a necessary precursor for implementation of QbD in process and product development. This article presents a review of major developments in this space in the last 10 years, with a special emphasis on those in last 5 years. A step by step approach for managing raw materials in the QbD paradigm has been proposed. We think that it is necessary for the biotech industry to better manage variability originating from raw materials if holistic implementation of QbD is to be achieved...
January 4, 2018: Current Opinion in Biotechnology
https://www.readbyqxmd.com/read/29305693/a-scale-up-approach-for-film-coating-process-based-on-surface-roughness-as-the-critical-quality-attribute
#4
Hiroyuki Yoshino, Yuko Hara, Masafumi Dohi, Kazunari Yamashita, Tadashi Hakomori, Shin-Ichiro Kimura, Yasunori Iwao, Shigeru Itai
Scale-up approaches for film coating process have been established for each type of film coating equipment from thermodynamic and mechanical analyses for several decades. The objective of the present study was to establish a versatile scale-up approach for film coating process applicable to commercial production that is based on critical quality attribute (CQA) using the Quality by Design (QbD) approach and is independent of the equipment used. Experiments on a pilot scale using the Design of Experiment (DoE) approach were performed to find a suitable CQA from surface roughness, contact angle, color difference, and coating film properties by terahertz spectroscopy...
January 5, 2018: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29248561/downstream-processing-from-melt-granulation-towards-tablets-in-depth-analysis-of-a-continuous-twin-screw-melt-granulation-process-using-polymeric-binders
#5
W Grymonpré, G Verstraete, V Vanhoorne, J P Remon, T De Beer, C Vervaet
The concept of twin-screw melt granulation (TSMG) has steadily (re)-gained interest in pharmaceutical formulation development as an intermediate step during tablet manufacturing. However, to be considered as a viable processing option for solid oral dosage forms there is a need to understand all critical sources of variability which could affect this granulation technique. The purpose of this study was to provide an in-depth analysis of the continuous TSMG process in order to expose the critical process parameters (CPP) and elucidate the impact of process and formulation parameters on the critical quality attributes (CQA) of granules and tablets during continuous TSMG...
December 14, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/29243216/lipid-a-adjuvanted-chylomicron-mimicking-solid-fat-nanoemulsions-for-immunization-against-hepatitis-b
#6
Sunita Minz, Ravi Shankar Pandey
Traditional parenteral recombinant hepatitis B virus (HBV) vaccines have effectively reduced the disease burden despite being able to induce seroprotective antibody titers in 5-10% vaccinated individuals (non-responders). Moreover, an estimated 340 million chronic HBV cases are in need of treatment. Development of safe, stable, and more effective hepatitis B vaccine formulation would address these challenges. Recombinant hepatitis B surface antigen (rHBsAg) entrapped solid fat nanoemulsions (SFNs) containing monophosphoryl lipid A (MPLA) that was prepared and optimized by quality by design (QbD) using response surface methodology (RSM), i...
December 14, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29221374/coherent-state-mapping-ring-polymer-molecular-dynamics-for-non-adiabatic-quantum-propagations
#7
Sutirtha N Chowdhury, Pengfei Huo
We introduce the coherent-state mapping ring polymer molecular dynamics (CS-RPMD), a new method that accurately describes electronic non-adiabatic dynamics with explicit nuclear quantization. This new approach is derived by using coherent-state mapping representation for the electronic degrees of freedom (DOF) and the ring-polymer path-integral representation for the nuclear DOF. The CS-RPMD Hamiltonian does not contain any inter-bead coupling term in the state-dependent potential and correctly describes electronic Rabi oscillations...
December 7, 2017: Journal of Chemical Physics
https://www.readbyqxmd.com/read/29218940/-studying-on-purification-technology-of-resina-draconis-phenol-extracts-based-on-design-space-method
#8
Jian Zhang, Xin Zhang, Yu-An Bi, Gui-Hong Xu, Wen-Zhe Huang, Zhen-Zhong Wang, Wei Xiao
The "design space" method was used to optimize the purification process of Resina Draconis phenol extracts by using the concept of "quality derived from design" (QbD). The content and transfer rate of laurin B and 7,4'-dihydroxyflavone and yield of extract were selected as the critical quality attributes (CQA). Plackett-Burman design showed that the critical process parameters (CPP) were concentration of alkali, the amount of alkali and the temperature of alkali dissolution. Then the Box-Behnken design was used to establish the mathematical model between CQA and CPP...
September 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29200316/scientific-statistical-practical-and-regulatory-considerations-in-design-space-development
#9
Veronika Debevec, Stanko Srčič, Matej Horvat
The quality by design (QbD) paradigm guides the pharmaceutical industry towards improved understanding of products and processes, and at the same time facilitates a high degree of manufacturing and regulatory flexibility throughout the establishment of the design space. This review article presents scientific, statistical and regulatory considerations in design space development. All key development milestones, starting with planning, selection of factors, experimental execution, data analysis, model development and assessment, verification, and validation, and ending with design space submission, are presented and discussed...
December 4, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/29198152/development-of-sustained-release-gastro-retentive-tablet-formulation-of-nicardipine-hydrochloride-using-quality-by-design-qbd-approach
#10
Vijay S Chudiwal, Sadhana Shahi, Swapnil Chudiwal
The objective of the present study was to develop sustained release gastro-retentive (SRGR) tablet formulation of Nicardipine Hydrochloride for once-a-day dosing using quality by design (QbD) approach. Quality target product profile (QTPP) of Nicardipine HCl SRGR tablet formulation was defined and critical quality attributes (CQAs) were identified. Potential risk factors were identified using a fish bone diagram and failure mode effect analysis (FMEA) tool and screened by Plackett-Burman design and finally Nicardipine HCl SRGR tablet formulation was optimized using Box-Behnken design...
December 2, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/29181272/new-insights-in-the-use-of-immunoglobulins-for-the-management-of-immune-deficiency-pid-patients
#11
REVIEW
Gergely Krivan, Stephen Jolles, Eduardo Lopes Granados, Phillipe Paolantonacci, Rabye Ouaja, Ousmane Alfa Cissé, Ewa Bernatowska
Immunoglobulin replacement therapy (IRT) is standard treatment for patients with primary immunodeficiency (PID). Because most of the patients with PID will require long life-time immunoglobulin replacement therapy, the quality of the prescribed products is of utmost importance. The IRT is generally administered either intravenously (abbreviated IVIG), or subcutaneously (abbreviated SCIG). Both routes have been demonstrated to be effective. The preferred route may vary at different times during a given patient's life...
2017: American Journal of Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/29171029/stress-degradation-of-edaravone-separation-isolation-and-characterization-of-major-degradation-products
#12
Madhuri Baghel, Sadhana J Rajput
In the present study ICH prescribed stress degradation was carried out to study the degradation profile of Edaravone. For establishing QbD assisted stability indicating assay, the reaction solutions in which different degradation products were formed were mixed. Plackett burman and central composite design was used to screen and optimize experimental variables to resolve Edaravone and its impurities with good peak symmetry using a RP C-18 column. The method was validated according to ICH guidelines. Seven unknown and two known degradation products were identified and characterized by LC-MS/MS...
November 23, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29158704/a-quality-by-design-approach-for-the-development-of-lyophilized-liposomes-with-simvastatin
#13
Alina Porfire, Dana Maria Muntean, Lucia Rus, Bianca Sylvester, Ioan Tomuţă
Lyophilization is used to ensure an increased shelf-life of liposomes, by preserving them in dry state, more stable than the aqueous dispersions. When stored as aqueous systems, the encapsulated drugs are released and the liposomes might aggregate or fuse. The aim of this study was to develop and optimize a lyophilized formulation of simvastatin (SIM) loaded into long circulating liposomes using the Quality by Design (QbD) approach. Pharmaceutical development by QbD aims to identify characteristics that are critical for the final product quality, and to establish how the critical process parameters can be varied to consistently produce a product with the desired characteristics...
November 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/29158287/development-of-a-premium-quality-plasma-derived-ivig-iqymune%C3%A2-utilizing-the-principles-of-quality-by-design-a-worked-through-case-study
#14
Philippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, Monique Ollivier, Richard Dennett, Laurent Siret
Polyvalent human normal immunoglobulins for intravenous use (IVIG), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A Quality by Design (QbD) approach has been used to develop the LFB new generation IVIG, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of QbD was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy...
November 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29154196/analysis-of-potential-genotoxic-impurities-in-rabeprazole-active-pharmaceutical-ingredient-via-liquid-chromatography-tandem-mass-spectrometry-following-quality-by-design-principles-for-method-development
#15
Katerina Iliou, Anđelija Malenović, Yannis L Loukas, Yannis Dotsikas
A novel Liquid Chromatography-tandem mass spectrometry (LC-MS/MS) method is presented for the quantitative determination of two potential genotoxic impurities (PGIs) in rabeprazole active pharmaceutical ingredient (API). In order to overcome the analytical challenges in the trace analysis of PGIs, a development procedure supported by Quality-by-Design (QbD) principles was evaluated. The efficient separation between rabeprazole and the two PGIs in the shortest analysis time was set as the defined analytical target profile (ATP) and to this purpose utilization of a switching valve allowed the flow to be sent to waste when rabeprazole was eluted...
November 12, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29137746/ultrasonically-tailored-chemically-engineered-and-qbd-enabled-fabrication-of-agomelatine-nanoemulsion-optimization-characterization-ex-vivo-permeation-and-stability-study
#16
Shakeeb Ahmed, Azka Gull, Mahtab Alam, Mohd Aqil, Yasmin Sultana
The objective of present study was to develop a nanoemulsion formulation of agomelatine (BCS class II drug) for the solubility enhancement. Capmul MCM, Tween 80 and PEG-400 were selected as oil, surfactant and co-surfactant respectively. The high energy ultrasonication method was used for the preparation of nanoemulsion. Three-factor three-level central composite design was employed to get the best formulation. The independent variables selected for the optimization were % oil, %Smix and sonication time (second)...
March 2018: Ultrasonics Sonochemistry
https://www.readbyqxmd.com/read/29136861/quality-by-design-approach-in-the-development-of-an-ultra-high-performance-liquid-chromatography-method-for-bexsero-meningococcal-group-b-vaccine
#17
Luca Nompari, Serena Orlandini, Benedetta Pasquini, Cristiana Campa, Michele Rovini, Massimo Del Bubba, Sandra Furlanetto
Bexsero is the first approved vaccine for active immunization of individuals from 2 months of age and older to prevent invasive disease caused by Neisseria meningitidis serogroup B. The active components of the vaccine are Neisseria Heparin Binding Antigen, factor H binding protein, Neisseria adhesin A, produced in Escherichia coli cells by recombinant DNA technology, and Outer Membrane Vesicles (expressing Porin A and Porin B), produced by fermentation of Neisseria meningitidis strain NZ98/254. All the Bexsero active components are adsorbed on aluminum hydroxide and the unadsorbed antigens content is a product critical quality attribute...
February 1, 2018: Talanta
https://www.readbyqxmd.com/read/29134556/process-optimization-and-particle-engineering-of-micronized-drug-powders-via-milling
#18
REVIEW
A Brunaugh, H D C Smyth
Process control and optimization is a critical aspect of process analytical technology (PAT), quality by design (QbD), and the implementation of continuous manufacturing procedures. While process control and optimization techniques have been utilized in other manufacturing industries for decades, the pharmaceutical industry has only recently begun to adopt these procedures. Micronization, particularly milling, is a generally low-yield, high-energy consumption process that is well suited for a process optimization mindset...
November 13, 2017: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29111491/uhplc-method-for-multiproduct-pharmaceutical-analysis-by-quality-by-design
#19
Ludivine Ferey, Adrien Raimbault, Isabelle Rivals, Karen Gaudin
An innovative Analytical Quality-by-Design (AQbD) methodology was followed to develop a specific and robust UHPLC method for the simultaneous separation of 16 active pharmaceutical ingredients (APIs). In the context of pharmaceutical repositioning, these molecules have been selected as good candidates for buccal per mucous (BPM(®)) administration route. Given the structural and physico-chemical diversity of compounds, an innovative development strategy based on QbD was applied. The main advantage of QbD is to ensure the robustness of the method...
October 16, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29107045/evaluation-of-a-biologic-formulation-using-customized-design-of-experiment-and-novel-multidimensional-robustness-diagrams
#20
Radhakrishna K Maroju, Steve Barash, Charlene Brisbane
Formulation development includes selection of appropriate excipients to stabilize the active pharmaceutical ingredient (API) throughout its recommended shelf-life, against potential excursions in its life cycle and sometimes to aid in delivery of the therapeutic into the patient. Identity and quantity of every ingredient in a therapeutic formulation are critical to achieve their intended purpose. Deviations from a target composition can result in manufacturing, safety and efficacy challenges. It is mandatory to establish robustness of a formulation for the expected changes in its composition arising from the qualified 'process variability' of the impacting process steps during manufacture...
October 26, 2017: Journal of Pharmaceutical Sciences
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