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Drug development: Improving analytical method performance through quality risk management and a design of experiments approach

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Join our webinar on Wednesday, September 4, for an overview of Quality by Design approaches to analytical method development

11 Aug 2019
Sarah Thomas
Associate Editor

Expert insights

It is now widely recognized that applying Quality by Design approaches to analytical method development (known as AQbD) has many benefits. AQbD is a science-based risk management approach to developing robust methods by identifying critical method parameters (CMPs) through risk assessment. This approach emphasizes the identification of the sources of variability, and their impact on method performance. By controlling these factors, the variability is reduced, thus leading to more robust methods. Typically, a design of experiments (DOE) approach is applied to identify and evaluate the effect of the most influential method parameters and any interactions between them.

In this webinar, Joseph A. Turpin, Director, Chromatography Products and Services from S-Matrix Corporation, and Tran Pham, Business Development Manager at Waters Corporation, will present an overview of AQbD and regulatory views, examples of DOE in AQbD and its benefits, and case studies demonstrating software assisted AQbD method development.

Join us for this webinar to learn about:

  • Benefits of addressing method challenges via risk assessment and DOE approaches
  • Improvement of method robustness and performance with a DOE approach and QbD method development software
  • Current thoughts around AQbD from the USP, FDA and ICH

After the presentation, you’ll also have the chance to put your questions to our speakers during a Q&A session.

REGISTER NOW

Who should attend:

  • Method developers and analytical scientists interested in learning how to improve method performance and ease method transfer
  • Managers interested in reducing the cost of poor-quality methods

The live webinar takes place on Wednesday, September 4, 2019, at:

  • 15:00 BST
  • 10:00 EDT
  • 07:00 PDT
  • 16:00 CEST

Scheduling conflict? No matter, register to receive an on-demand link to watch later>>

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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.LC-MSLC-MS (liquid chromatography-mass spectrometry) systems and equipment are used for separation and quantitative analysis of complex mixtures, combining liquid chromatography and mass spectrometry. Quantify proteins, contaminants, pesticides or screen for drug metabolites with a high level of sensitivity. LC-MS systems and equipment include reverse phase, normal phase and specialized columns integrated with various MS detectors such as time-of-flight (TOF), quadrupole, orbitrap or ion trap mass analyzers. LC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzer give greater sensitivity and resolving power to your analysis. Find the best LC-MS equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer. GC-MS GC-MS (gas chromatography-mass spectrometry) instruments and equipment are used to separate, quantify and identify mixtures of small and volatile compounds, such as polycyclic aromatics, fatty acids and alcohols. Often used in drug detection, forensic investigation and environmental analysis for pesticides and contaminants, GC-MS is a powerful addition to your lab’s analytical capabilities. GC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzers can give greater sensitivity and resolution to your analysis. Find the best GC-MS instruments and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Method DevelopmentMethod development is the process of creating and optimizing experimental techniques and protocols to achieve reliable, reproducible results. This is essential in various fields, including pharmaceuticals, environmental science, and diagnostics. Browse our peer-reviewed product directory to find the best method development solutions, compare products, check reviews, and get pricing directly from manufacturers.Quality TestingQuality testing ensures that products meet required specifications and safety standards in various industries, including pharmaceuticals, food, and materials. It is essential for maintaining product quality and consumer safety. Explore quality testing tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.USP Method

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