Log in

Relevant bibliographies by topics / Analytical Quality by Design (aQbD) / Journal articles

To see the other types of publications on this topic, follow the link: Analytical Quality by Design (aQbD).

Journal articles on the topic 'Analytical Quality by Design (aQbD)'

Author: Grafiati

Published: 7 June 2025

Last updated: 2 August 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the top 50 journal articles for your research on the topic 'Analytical Quality by Design (aQbD).'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.

1

Peraman, Ramalingam, Kalva Bhadraya, and Yiragamreddy Padmanabha Reddy. "Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics." International Journal of Analytical Chemistry 2015 (2015): 1–9. http://dx.doi.org/10.1155/2015/868727.

Full text

Abstract:

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of t

APA, Harvard, Vancouver, ISO, and other styles

2

Park, Geonha, Min Kyoung Kim, Seung Hyeon Go, Minsik Choi, and Young Pyo Jang. "Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants." Plants 11, no. 21 (2022): 2960. http://dx.doi.org/10.3390/plants11212960.

Full text

Abstract:

Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years. AQbD is a holistic method and development approach that understands analytical procedure, from risk assessment to lifecycle management. The enhanced AQbD approach reduces the time and effort necessary to develop reliable analytical methods, leads to flexible change control through the method oper

APA, Harvard, Vancouver, ISO, and other styles

3

Alhakeem, Maher Abdulrazzaq, Mihaela Violeta Ghica, Cristina Dinu Pîrvu, Valentina Anuța, and Lăcrămioara Popa. "Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development." Acta Medica Marisiensis 65, no. 2 (2019): 37–44. http://dx.doi.org/10.2478/amma-2019-0010.

Full text

Abstract:

AbstractQuality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of development of a product, the control process, which is built on risk management and comprehensive knowledge of science. The concept of QbD applied to analytical method development is known now as AQbD (Analytical Quality by Design). Comprehension of the Analytical Target Profile (ATP) and the risk assessment for the variables that can have an impact on the productivity of the developed analytical method can be the main principles of the A

APA, Harvard, Vancouver, ISO, and other styles

4

L., P. Jain*1 M. S. Charde1 S. J. Momin1 S. V. Potdar2 N. D. Kulkarni1. "Quality by Design in HPTLC: A Review of Method Development Approaches." International Journal of Scientific Research and Technology 2 (June 3, 2025): 179–97. https://doi.org/10.5281/zenodo.15585927.

Full text

Abstract:

A methodical approach to development, Quality by Design (QbD) starts with predetermined goals for a product, process comprehension, and process control based on knowledge and quality risk management. When developing and validating a traditional approach, it is possible that it will not achieve the desired outcome. AQbD is the application of the QbD idea to the validation of analytical  methods. A systematic and trustworthy strategy for developing analytical processes that cover all stages of a product's lifecycle is offered by AQbD.  The AQbD technique for creating the HPTLC method i

APA, Harvard, Vancouver, ISO, and other styles

5

Bhosale, Abhilash, Shubhangi Darekar, V. U. Barge Dr., and Ashok Bhosale Dr. "Analytical Quality by Design Concise Review on Approach to Enhanced Analytical Method Development." International Journal of Trend in Scientific Research and Development 4, no. 3 (2020): 543–46. https://doi.org/10.5281/zenodo.3892381.

Full text

Abstract:

In the last few decades, the pharmaceutical industry has been rapidly progressing by focussing on various aspects of formulation and analytical development such as product Quality, Safety, and Efficacy. It is reflected through the increase in number of product development by the increased use of scientific tools such as QbD Quality by Design and PAT Process Analytical Technology . ICH guidelines Q8 to Q11 have specified QbD implementation in API synthetic process and also in formulation as well as analytical development. QbD has earned considerable reputation by formulation developers. It has

APA, Harvard, Vancouver, ISO, and other styles

6

Raman, N. V. V. S. S., Useni Reddy Mallu, and Hanimi Reddy Bapatu. "Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing." Journal of Chemistry 2015 (2015): 1–8. http://dx.doi.org/10.1155/2015/435129.

Full text

Abstract:

Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development. ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. Generic companies are implementing QbD approach in formulation development and even it is mandatory for USFDA perspe

APA, Harvard, Vancouver, ISO, and other styles

7

Mohammad, Tarikul Islam Bossunia, Farjana Urmi Khandokar, and Chironjit Kumar Shaha. "Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation." Pharmaceutical Methods 8, no. 2 (2017): 01–10. https://doi.org/10.5281/zenodo.14856243.

Full text

Abstract:

Context: Stability Indicating RP-HPLC analytical method validation for estimation of Canagliflozin API have been reported, but there are not studies related to the application of Analytical Quality by Design (AQbD) concepts to the development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API). Aim: Development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API) according to An

APA, Harvard, Vancouver, ISO, and other styles

8

Dewi, Mayang, Reza Pratama, Mia Arifka, and Anis Chaerunisaa. "Quality By Design: Approach to Analytical Method Validation." Sciences of Pharmacy 1, no. 1 (2022): 33–40. http://dx.doi.org/10.58920/sciphar01010033.

Full text

Abstract:

A pharmaceutical industry is highly regulated by a quality policy in its management. The principles of Quality by Design (QbD) must be applied to ensure the development of pragmatic and systematic methods while managing the risks associated with analytical methods. Quality by Design (QbD) is a scientific way to develop easy and robust analytical techniques for critical analysis. Quality by Design (QbD) is a systematic approach to product or method development that starts with predetermined goals and uses a science and risk management approach to achieve product and method understanding. The co

APA, Harvard, Vancouver, ISO, and other styles

9

Basso, João, Maria Mendes, Tânia F. G. G. Cova, João J. Sousa, Alberto A. C. C. Pais, and Carla Vitorino. "Analytical Quality by Design (AQbD) as a multiaddressable platform for co-encapsulating drug assays." Analytical Methods 10, no. 47 (2018): 5659–71. http://dx.doi.org/10.1039/c8ay01695j.

Full text

APA, Harvard, Vancouver, ISO, and other styles

10

Basso, João, Maria Luísa Ramos, Alberto Pais, Rui Vitorino, Ana Fortuna, and Carla Vitorino. "Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach." Chemosensors 9, no. 7 (2021): 172. http://dx.doi.org/10.3390/chemosensors9070172.

Full text

Abstract:

An Analytical Quality by Design (AQbD) approach is presented, aiming at the development and validation of an HPLC method for the quantification of disulfiram and copper diethyldithiocarbamate in lipid nanoparticles. Following the definition of the analytical target profile (ATP), encompassing the critical analytical attributes (CAA), a two-level risk assessment strategy (Ishikawa diagram—failure mode and effect analysis (FMEA)) was employed to identify the critical method parameters (CMPs) with an extensive impact on method performance. The behavior of the CMPs (flow rate and mobile phase comp

APA, Harvard, Vancouver, ISO, and other styles

11

Orlandini, Serena, Gabriel Hancu, Zoltán-István Szabó, et al. "New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods." Molecules 27, no. 20 (2022): 7058. http://dx.doi.org/10.3390/molecules27207058.

Full text

Abstract:

Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices. The adoption of Quality by Design (QbD) concepts in analytical method development, optimization and validation is a widespread trend observed in various analytical approaches including chiral CE. The application of Analytical QbD (AQbD) leads to the development of analytical methods based on sound science combined with risk management, and to a well understood process clarifying the influence of met

APA, Harvard, Vancouver, ISO, and other styles

12

Wagh, Sneha Sunil* R. B. Darade. "Analytical Quality by Design: A Systematic Review." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1120–26. https://doi.org/10.5281/zenodo.11235349.

Full text

Abstract:

At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

APA, Harvard, Vancouver, ISO, and other styles

13

Randive, Krantisinha Hanumant, Meenaxi Maruti Maste, and Amolkumar Ashok Kempwade. "Exploring Analytical Quality by Design (AQbD) Enabled RP-HPLC Method for Carvedilol." Indian Journal of Pharmaceutical Education and Research 58, no. 2 (2024): 651–60. http://dx.doi.org/10.5530/ijper.58.2.73.

Full text

APA, Harvard, Vancouver, ISO, and other styles

14

Chanduluru, Hemanth Kumar, and Abimanyu Sugumaran. "Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using Green Analytical Quality by Design-based UPLC Method." RSC Advances 11, no. 45 (2021): 27820–31. http://dx.doi.org/10.1039/d1ra04843k.

Full text

Abstract:

Analysing isosorbide dinitrate and hydralazine by using an eco-friendly method is an initial stepping stone towards environmentally benign method development, and its combination with the AQbD makes it the method to use for ages without revalidation.

APA, Harvard, Vancouver, ISO, and other styles

15

Chiarentin, Lucas, Catarina Cardoso, Margarida Miranda, and Carla Vitorino. "Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation." Pharmaceutics 15, no. 7 (2023): 1810. http://dx.doi.org/10.3390/pharmaceutics15071810.

Full text

Abstract:

Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied semisolid formulations are one of the key elements involved in microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it is a dire need to take a step forward in rheology method development and validation procedures. This paper aims to apply Analytical Quality by Design (AQbD) principles towards the develo

APA, Harvard, Vancouver, ISO, and other styles

16

Yao, Han, Jochem Vancoillie, Matthias D’Hondt, Evelien Wynendaele, Nathalie Bracke, and Bart De Spiegeleer. "An analytical quality by design (aQbD) approach for a l -asparaginase activity method." Journal of Pharmaceutical and Biomedical Analysis 117 (January 2016): 232–39. http://dx.doi.org/10.1016/j.jpba.2015.08.042.

Full text

APA, Harvard, Vancouver, ISO, and other styles

17

K, Nithiyananthan, and Prasada Rao KVS. "VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GLECAPREVIR AND PIBRENTASVIR BY USING ANALYTICAL QUALITY BY DESIGN (AQBD) METHOD." International Journal of Research in Ayurveda and Pharmacy 14, no. 5 (2023): 27–36. http://dx.doi.org/10.7897/2277-4343.1405140.

Full text

Abstract:

The quantitative measurement of Glecaprevir and Pibrentasvir has been created using a simple, quick, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method. It is more difficult to analyse varying amounts of pharmaceutical active medicinal ingredients in dosage forms without interferences. Therefore, the objective of the current work is to estimate Glecaprevir and Pibrentasvir simultaneously by adopting an Analytical Quality by Design (AQbD), a rotatable central composite-based technique using RP-HPLC-based method development and validation.

APA, Harvard, Vancouver, ISO, and other styles

18

Vasquez-Huaman, Miguel, Américo Castro-Luna, Norma Julia Ramos-Cevallos, et al. "Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide 131I Oral Solution." Molecules 29, no. 8 (2024): 1883. http://dx.doi.org/10.3390/molecules29081883.

Full text

Abstract:

The goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer chromatography (TLC) with a radio–TLC scanner, which also enables the evaluation of product quality. For AQbD, the analytical target profile (ATP), critical quality attributes (CQA), risk management, and the method operable design region (MODR) were defined through response surface methodology to optimize the method using MINITAB® 19 software. This study

APA, Harvard, Vancouver, ISO, and other styles

19

Sunitha, G., P. D. Anumolu, C. V. S. Subrahmanyam, G. Mounika, and B. Priyanka. "STABILITY INDICATING LIQUID CHROMATOGRAPHIC ASSESSMENT OF DOLUTEGRAVIR BY AQBD APPROACH – CENTRAL COMPOSITE DESIGN." INDIAN DRUGS 54, no. 10 (2017): 44–51. http://dx.doi.org/10.53879/id.54.10.11138.

Full text

Abstract:

Based on the current regulatory requirements for analytical method development, a RP-HPLC method for quality control of dolutegravir in dosage form has been optimized using analytical quality by design (AQbD) approach. Experimental observations were analysed by full factorial experimental design in Sigmatech software with two variables (flow rate and % organic mobile phase) whilst the number of theoretical plates was considered as response. The analytical method conditions were optimized as mobile phase (40:60 % V/V) consisting of acetonitrile and ammonium formate buffer, pH 3.0 pumped at a fl

APA, Harvard, Vancouver, ISO, and other styles

20

Bandopadhyay, Shantanu, Sarwar Beg, O. P. Katare, Teenu Sharma, and Bhupinder Singh. "Integrated Analytical Quality by Design (AQbD) Approach for the Development and Validation of Bioanalytical Liquid Chromatography Method for Estimation of Valsartan." Journal of Chromatographic Science 58, no. 7 (2020): 606–21. http://dx.doi.org/10.1093/chromsci/bmaa024.

Full text

Abstract:

Abstract The present studies describe the systematic development and validation of a simple, rapid, sensitive and cost-effective reversed-phase high-performance liquid chromatographic bioanalytical method for the estimation of valsartan in rat plasma employing analytical quality by design (AQbD) principles quality risk management was applied for identifying the critical method parameters (CMPs) and subsequently method optimization was performed employing Box–Behnken design by selecting mobile phase pH, flow rate and % organic modifier as the CMPs and evaluated for critical analytical attribute

APA, Harvard, Vancouver, ISO, and other styles

21

Harish, Vancha, Waleed Hassan Almalki, Ahmed Alshehri, et al. "Quality by Design (QbD) Based Method for Estimation of Xanthohumol in Bulk and Solid Lipid Nanoparticles and Validation." Molecules 28, no. 2 (2023): 472. http://dx.doi.org/10.3390/molecules28020472.

Full text

Abstract:

The analytical quality by design (AQbD) approach is utilized for developing and validating the simple, sensitive, cost-effective reverse-phase high performance liquid chromatographic method for the estimation of xanthohumol (XH) in bulk and nanoformulations. The Box–Behnken design (BBD) is applied for method optimization. The mobile phase ratio, pH and flow rate were selected as independent variables, whereas retention time, peak area, peak height, tailing factor, and theoretical plates were selected as dependent variables. The chromatogram of XH obtained under optimized conditions has given o

APA, Harvard, Vancouver, ISO, and other styles

22

Kanchan, Shinde* Neha Gaikwad Varsha Pangale Charushila Bhangale. "A Review On Development And Validation Of Ultra Performance Liquid Chromatography For Estimation Of Drug In Pharmaceutical Dosage Form By Quality By Design (Qbd) Approach." Int. J. in Pharm. Sci. 1, no. 7 (2023): 123–38. https://doi.org/10.5281/zenodo.8112767.

Full text

Abstract:

The pharmaceutical business, system optimization, stationary phase vs mobile phase, detector design, data processing, and data integrity control have all seen notable technical advancements in recent years. The individual accomplishments in each subject have led to a step-function increase in technique and performance when technology and quality are combined. A new method of using liquid chromatography for sample detection is provided by ultra-performance liquid chromatography (UPLC). UPLC primarily improves the resolution, speed, and sensitivity of liquid chromatography. UPLC approach uses Qu

APA, Harvard, Vancouver, ISO, and other styles

23

Afonso Urich, Jesús Alberto, Viktoria Marko, Katharina Boehm, Raymar Andreína Lara García, Dalibor Jeremic, and Amrit Paudel. "Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles." Molecules 26, no. 21 (2021): 6597. http://dx.doi.org/10.3390/molecules26216597.

Full text

Abstract:

A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, which are aligned with the future requirements from the regulatory agencies using AQbD principles. The method was developed by assessing the impact of ion pairing, the chromatographic column, pH and gradient elution. The development was achieved with a Waters Acquity HSS T3 (50 ×

APA, Harvard, Vancouver, ISO, and other styles

24

Kaur, Ranjot, Sumant Saini, Asha Patel, et al. "Developing a Validated HPLC Method for Quantification of Ceftazidime Employing Analytical Quality by Design and Monte Carlo Simulations." Journal of AOAC INTERNATIONAL 104, no. 3 (2021): 620–32. http://dx.doi.org/10.1093/jaoacint/qsab014.

Full text

Abstract:

Abstract Background Ceftazidime, a third-generation cephalosporin, is widely used in the treatment of lung infections, often given as “off-label” nebulization. There is a need to develop a sensitive and robust analytical method to compute aerodynamic properties of ceftazidime following nebulization. Objective The current study entails development of a simple, accurate, and sensitive HPLC method for ceftazidime estimation, employing the principles of analytical quality-by-design (AQbD) and Monte Carlo simulations. Method Selection of critical material attributes (CMAs) affecting method performa

APA, Harvard, Vancouver, ISO, and other styles

25

Gaytri, Anil More ¹* Shital Pande². "Formulation And Evaluation Of Ashwagandha Kalpa Of Ayurveda For Apasmara (Epilepsy)." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1691–710. https://doi.org/10.5281/zenodo.11386977.

Full text

Abstract:

At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

APA, Harvard, Vancouver, ISO, and other styles

26

Pavan, khonde Swati Jadhav* Aman Upaganlawar Chandrashekhar Upasani. "Cell and Gene Therapy in Cancer." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1453–69. https://doi.org/10.5281/zenodo.11319242.

Full text

Abstract:

At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

APA, Harvard, Vancouver, ISO, and other styles

27

Siddhant, M. Sawant* Prashant J. Burange Maithili P. Amale Pankaj H. Chaudhary. "A Review Article On Transforming Parkinson's Disease Care :Innovative Treatment Strategies Revealed." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1522–43. https://doi.org/10.5281/zenodo.11351692.

Full text

Abstract:

At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

APA, Harvard, Vancouver, ISO, and other styles

28

Bagad, Kunal S., Kunal Bacchao, Shashikant B. Bagade, Rakesh D. Amrutkar, and Dipak D. Patil. "RP-HPLC Estimation of Clobetasol Propionate and Salicylic Acid using Quality by Design Approach." Biosciences Biotechnology Research Asia 21, no. 1 (2024): 283–94. http://dx.doi.org/10.13005/bbra/3225.

Full text

Abstract:

ABSTRACT: The RP-HPLC method for CLOP and SA estimation from bulk and pharmaceutical dosage from has been developed and validated. For analytical methods to be robust, current ICH guidelines, Q8 to Q11 were suggested use of analytical quality by design (AQbD) includes adoption of current systematic approaches. The proposed method was optimized and developed using Taguchi orthogonal design. The RP-HPLC method parameters were optimized by box- Behnken design. The stationary phase used C18 Princeton column (150mm × 4.6mm × 5µm) with acetonitrile: 0.05M phosphate buffer (pH 2.5, adjustment with by

APA, Harvard, Vancouver, ISO, and other styles

29

Gopalaiah, Sinchana B., and Kavitha Jayaseelan. "Analytical quality by design approach to develop an eco-friendly RP-HPLC method for estimation of irbesartan in chitosan polymeric nanoparticles: forced degradation studies and assessment of in vitro release mathematical modelling." RSC Advances 14, no. 31 (2024): 22169–84. http://dx.doi.org/10.1039/d4ra03952a.

Full text

APA, Harvard, Vancouver, ISO, and other styles

30

Purva, Patel*1 Arjun Chaudhari2 Akash Patel1. "Discriminative Dissolution Development and Validation of Poorly Soluble Drugs Using Method Operable Design Region." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 950–65. https://doi.org/10.5281/zenodo.15350900.

Full text

Abstract:

Establishing reliable and discriminative dissolution methods is critical for maintaining the quality and batch consistency of poorly soluble drug formulations—a process often hindered by conventional development techniques. This review emphasizes the transformative benefits of implementing structured Quality by Design (QbD) and Analytical QbD (aQbD) methodologies. By employing Design of Experiments (DoE), a Method Operable Design Region (MODR) can be optimized to guarantee method robustness. Additionally, implementing systematic evaluation protocols—such as defining a Method Discri

APA, Harvard, Vancouver, ISO, and other styles

31

Shah, Kunti Abhishek, and Vijaykumar Kunvarji Parmar. "Quality by Design Based Method Development for Simultaneous Estimation of Montelukast Sodium and Theophylline in Tablet Dosage Form." Current Pharmaceutical Analysis 15, no. 6 (2019): 612–23. http://dx.doi.org/10.2174/1573412914666180827143700.

Full text

Abstract:

Background: Analytical Quality by design (AQbD) is one of the upcoming regulatory requirements in the field of pharmaceutical analysis for the development of reliable and robust analytical methods. Montelukast sodium and theophylline available in tablet dosage forms are used widely for the treatment of airway disorders. Liquid chromatographic methods for estimation of the drugs are reported but those chromatographic methods developed by the AQbD approach are not available. Methods: A systematic design of experiments has been employed to develop a liquid chromatographic method for simultaneous

APA, Harvard, Vancouver, ISO, and other styles

32

Ameen, Shaik Ayesha, and Nagaraju Pappula. "Analytical QBD Approach to Redefine the Quality of Pharmaceuticals: A Review." Journal of Pharmaceutical Research 22, no. 4 (2023): 178–85. http://dx.doi.org/10.18579/jopcr/v22.4.81.

Full text

Abstract:

As per the present scenario traditional techniques of quality by testing of finished pharmaceutical products have proved to be unsatisfactory, although focus on 'Total quality assurance can be attained only by in-process testing and analysis. The Quality by Design (QbD) idea has already been established and applied in all nations that adhere to the International Conference on Harmonization Guidelines. The proposed ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems offer a foundation for incorporating quality into the pro

APA, Harvard, Vancouver, ISO, and other styles

33

Pal, Ashish K., and Raja Sundararajan. "A Stability Demonstrating HPLC Method Development and Validation for Related Substances in Oxtriphylline using Quality by Design." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 14, no. 01 (2023): 45–53. http://dx.doi.org/10.25258/ijpqa.14.1.09.

Full text

Abstract:

A new reverse phase HPLC procedure, stability demonstrating for estimating related substances in oxtriphylline, was developed and validated according to ICH guidelines by applying Analytical Quality by Design (AQbD) principles. The three critical method parameters identifi ed were mobile phase fl ow rate, column temperature, and mobile phase pH. Based on these factors, the resolution between oxtriphylline and theophylline related compound F and the tailing of oxtriphylline peak were selected as critical method attributes. XBridge BEH C18 with measurements 150 x 4.6 mm, 5 μ was used to achieve

APA, Harvard, Vancouver, ISO, and other styles

34

Teng, Jianhao, Chunmei Zhu, Jinyuan Lyu, et al. "Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets." Journal of Pharmaceutical and Biomedical Analysis 207 (January 2022): 114417. http://dx.doi.org/10.1016/j.jpba.2021.114417.

Full text

APA, Harvard, Vancouver, ISO, and other styles

35

Morparia, Saurabh, Chaitanya Metha, Shrutee Pawar, and Vasanti Suvarna. "DEVELOPMENT AND OPTIMIZATION OF A QUALITY BY DESIGN-DRIVEN HPLC METHOD FOR CURCUMIN QUANTIFICATION." INDIAN DRUGS 62, no. 06 (2025): 37–44. https://doi.org/10.53879/id.62.06.15279.

Full text

Abstract:

The research study involves development and validation of a robust RP-HPLC technique for curcumin quantification using Analytical Quality by Design (AQbD). Key method parameters such as composition of mobile phase, temperature of column, and flow rate were optimized using a 33 -level factorial design. The method performance was evaluated based on chromatographic attributes, which include number of theoretical plates, peak area, retention time, and height equivalent to a theoretical plate. Various optimal conditions were identified within the experimental space through numerical and graphical a

APA, Harvard, Vancouver, ISO, and other styles

36

Stajić, A., J. Janković-Maksić, B. Jančić-Stojanović, and M. Medenica. "AQbD-Oriented UHPLC/MS/MS Method Development for Glycopeptides Assessment in Pharmaceutical Forms." Journal of Chromatographic Science 59, no. 7 (2021): 650–58. http://dx.doi.org/10.1093/chromsci/bmab004.

Full text

Abstract:

Abstract Vancomycin and teicoplanin are glycopeptide antibacterials that inhibit the bacteria cell wall synthesis showing activity against gram-positive bacteria. Development of the sensitive method is of great importance for quality control of these drugs that are fermentation products. Modification of the fermentation conditions could cause the differences in the relative amount of the total substance or component, as it is the case with teicoplanin. The main objective of this study was development of the sensitive and effective ultra high performance liquid chromatography - tandem mass spre

APA, Harvard, Vancouver, ISO, and other styles

37

Szoleczky, Réka, Mária Budai-Szűcs, Erzsébet Csányi, et al. "Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel." Pharmaceutics 14, no. 4 (2022): 707. http://dx.doi.org/10.3390/pharmaceutics14040707.

Full text

Abstract:

The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-high-performance liquid chromatography were defined; the critical method attributes (CMAs) (min. 70% of the drug should be released during the test, six time points should be obtained in the linear portion of the drug release profile, and the relative standard deviation of the released drug should not

APA, Harvard, Vancouver, ISO, and other styles

38

Panda, Sagar Suman, Venkata Varaha Ravi Kumar Bera, Sarwar Beg, and Omkar Mandal. "Analytical Quality by Design (AQbD)-oriented RP-UFLC method for quantification of lansoprazole with superior method robustness." Journal of Liquid Chromatography & Related Technologies 40, no. 9 (2017): 479–85. http://dx.doi.org/10.1080/10826076.2017.1327442.

Full text

APA, Harvard, Vancouver, ISO, and other styles

39

Rmandić, Milena, Đorđe Vasilić, Marija Rašević, et al. "Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination." Pharmaceuticals 16, no. 9 (2023): 1296. http://dx.doi.org/10.3390/ph16091296.

Full text

Abstract:

In this study, an AQbD-compliant chaotropic chromatography method for ziprasidone and the determination of its five impurities was developed. The influence of critical method parameters (initial and final methanol fraction in the mobile phase, gradient duration) on the set of selected critical method attributes (t_imp. V, t_imp. V − t_imp. I, S and <WUSP>) was studied by Box–Behnken design. The errors resulting from the calculation of the model coefficients were propagated to the selected responses by Monte Carlo simulations, and their predictive distribution was obtained. The design spa

APA, Harvard, Vancouver, ISO, and other styles

40

Moolakkadath, Thasleem, Mohd Aqil, Syed Sarim Imam, et al. "Analytical Quality by Design (AQbD) Approach Based HPTLC Method for Quantification of Fisetin with Superior Recovery in Formulations." Current Analytical Chemistry 16, no. 2 (2020): 149–57. http://dx.doi.org/10.2174/1573411014666180627145031.

Full text

Abstract:

Background: A stability indicating high-performance thin layer chromatography (HPTLC) method was developed for the evaluation of fisetin (FIS) in active pharmaceutical ingredient (API) and marketed capsule formulation in accordance with the ICH guidelines. Methods: The mobile phase combination toluene: ethyl acetate: formic acid: methanol (3: 5.5: 1: 0.5 v/v/v/v) was optimized with the aid of AQbD approach. The absorbance mode at 254 nm was chosen for densitometric analysis as it gives a compact spot of FIS at Rf value of 0.74. Results: The R2 value obtained from the linear regression equation

APA, Harvard, Vancouver, ISO, and other styles

41

Chiarentin, Lucas, Vera Moura, Alberto A. C. C. Pais, and Carla Vitorino. "AQbD Approach Applied to NIR in a Complex Topical Formulation: Bifonazole as Case Study." Pharmaceutics 17, no. 7 (2025): 835. https://doi.org/10.3390/pharmaceutics17070835.

Full text

Abstract:

Background: A key challenge in modern pharmaceutical research is developing predictive models for drug formulation behavior. Since permeability is closely linked to molecular properties, considering a broad of characteristics is essential for building reliable predictive tools. Near-infrared spectroscopy (NIR), a non-destructive, non-invasive, and chemically specific method, offers a powerful alternative to current gold-standard methods approved by regulatory agencies. Objectives: This study aims to apply a partial analytical quality by design (AQbD) approach to enhance the understanding and d

APA, Harvard, Vancouver, ISO, and other styles

42

Vyas, Amitkumar J., Dhruvanshi A. Gol, Ajay I. Patel, et al. "Implementing Analytical Quality by Design (AQbD) Approach for Simultaneous Estimation of Tadalafil and Macitentan by RP-HPLC Method." Analytical Chemistry Letters 11, no. 4 (2021): 539–52. http://dx.doi.org/10.1080/22297928.2021.1938215.

Full text

APA, Harvard, Vancouver, ISO, and other styles

43

Stojanović, Jevrem, Jovana Krmar, Ana Protić, Bojana Svrkota, Nevena Đajić, and Biljana Otašević. "Experimental design in HPLC separation of pharmaceuticals." Arhiv za farmaciju 71, no. 4 (2021): 279–301. http://dx.doi.org/10.5937/arhfarm71-32480.

Full text

Abstract:

Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC). This manuscript briefly outlines the theoretical background of the DOE and provides step-by-step instruction for its implementation in HPLC pharmaceutical practice. It particularly discusses the classification of various design types and their possibilities to rationalize the different stages of HPLC method development workflow, such as the selection of the most influen

APA, Harvard, Vancouver, ISO, and other styles

44

Gkountanas, Kostas, Anđelija Malenović, and Yannis Dotsikas. "Determination of Bupropion and Its Impurities via a Chaotropic Chromatography Method Following Analytical Quality-by-Design Principles for Method Development." Pharmaceuticals 15, no. 10 (2022): 1196. http://dx.doi.org/10.3390/ph15101196.

Full text

Abstract:

A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented. The analytical target profile (ATP) was defined on the basis of the efficient separation and reliable determination of bupropion and its five impurities in tablets. Preliminary experiments revealed the need for the addition of a gradient elution part. A screening fractional factorial experimental design was employed to select the critical method parameters (CMPs) and a Box–Behnken design (BBD) was utilized to invest

APA, Harvard, Vancouver, ISO, and other styles

45

Singh, Ankit Kumar, Yogita Vashitha, Ashita Jain, Ghanshyam Das Gupta, and Sant Kumar Verma. "A Review on Advancement in Analytical Quality by Design (AQbD)." Current Analytical Chemistry 21 (October 7, 2024). http://dx.doi.org/10.2174/0115734110321580240924073705.

Full text

Abstract:

Analytical Quality by Design (AQbD) represents a transformative methodology in pharmaceutical development, anchored in a systematic, risk-based, and data-driven framework. This approach optimizes analytical methods, fostering heightened product quality, efficient regulatory compliance, and informed decision-making. The industry's increasing acceptance of AQbD principles signifies a paradigm shift towards enhanced efficiency, sustainability, and global harmonization. This review comprehensively explores AQbD principles, regulatory perspectives, and its applications, particularly in analytical m

APA, Harvard, Vancouver, ISO, and other styles

46

Verch, Thorsten, Cristiana Campa, Cyrille C. Chéry, et al. "Analytical Quality by Design, Life Cycle Management, and Method Control." AAPS Journal 24, no. 1 (2022). http://dx.doi.org/10.1208/s12248-022-00685-2.

Full text

Abstract:

AbstractAnalytical methods are utilized throughout the biopharmaceutical and vaccines industries to conduct research and development, and to help control manufacturing inputs and outputs. These analytical methods should continuously provide quality data to support decisions while managing the remaining of risk and uncertainty. Analytical quality by design (AQbD) can provide a systematic framework to achieve a continuously validated, robust assay as well as life cycle management. AQbD is rooted in ICH guidelines Q8 and Q9 that were translated to the analytical space through several white papers

APA, Harvard, Vancouver, ISO, and other styles

47

P., Abhinandana1.2* Ramarao Nadendla2. "IMPLEMENTING OF ANALYTICAL QUALITY BY DESIGN FOR HIGH QUALITY PHARMACEUTICAL PRODUCTS." July 31, 2017. https://doi.org/10.5281/zenodo.2526723.

Full text

Abstract:

The quality in the pharmaceutical industry has become a very important topic. Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. The guidelines of ICH from Q8 to Q11 have discussed QbD implementation in pharmaceutical product formulation development. ICH Q11 is a clear discussion about QbD approach for API (Active Pharmaceutical Ingredient) synthesis with examples. Pharmaceutical firms increased the number of product development by using different scientific tools such as QbD (Quality by Design) and PAT (Process Analytica

APA, Harvard, Vancouver, ISO, and other styles

48

Kanthiah, Selvakumar, J. Joysa Ruby, Hiriyanna SGB, and Valliappan Kannappan. "Navigating the AQbD Landscape: Enhancing Quality Management in Liquid Chromatography Method Development." Biomedical Chromatography 39, no. 4 (2025). https://doi.org/10.1002/bmc.70031.

Full text

Abstract:

ABSTRACTThe implementation of ‘Analytical Quality by Design’ (AQbD) is currently recognised as a methodical and scientific approach to liquid chromatographic (LC) method development. It begins with defining the Analytical Target Profile (ATP), identifying Critical Method Parameters (CMPs) and Critical Quality Attributes (CQAs) or responses. This process also includes risk assessment study by Design of Experiment (DoE) and to optimise LC effectively. The next step is to create an analytical design space and implement a control strategy that will allow for continuous method improvement over the

APA, Harvard, Vancouver, ISO, and other styles

49

Bairagi, Amruta, Rutuja Kothrukar, Hemant Chikhale, Sreya Kosanam, and Laxmikant Borse. "AQbD-novel strategy for analytical methods." Future Journal of Pharmaceutical Sciences 10, no. 1 (2024). http://dx.doi.org/10.1186/s43094-024-00706-1.

Full text

Abstract:

Abstract Background Analytical Quality by Design (AQbD) has emerged as a pivotal paradigm in the realm of analytical chemistry, revolutionizing the approach to method development and validation. This innovative strategy integrates principles of Quality by Design (QbD) into analytical procedures, aiming to ensure the quality and robustness of analytical methods. The traditional approach to method development often involves a trial-and-error process, where parameters are adjusted until satisfactory results are obtained. However, this approach can be time-consuming, resource-intensive, and may la

APA, Harvard, Vancouver, ISO, and other styles

50

Chopra, Shruti, Prashant K. Chaturvedi, Kalyani H. Joshi, Savita J. Tauro, and Pintu B. Prajapati. "Pitfalls and Opportunities in the Execution of Quality by Design in Analytical Sciences." Current Pharmaceutical Analysis 19 (May 17, 2023). http://dx.doi.org/10.2174/1573412919666230517141015.

Full text

Abstract:

Abstract: Quality by Design (QbD) is a systematic approach integrated with quality risk management. It uses different design approaches followed by statistical analysis to yield a quality product. Now, the pharmaceutical industries are intrested in the application of QbD principles to analytical methods and term it as Analytical QbD (AQbD), which does not essentially mean less analytical testing; to a particular extent, it means the right analysis at the right time, supported by science and risk evaluation which ensures that the analytical method can be improved throughout its life cycle. Howe

APA, Harvard, Vancouver, ISO, and other styles

We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!