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Case Studies of Foreign Particulate Analysis

Authors & ContributorsDavid Exline January 23, 2019 Topics covered include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and a review of case studies. The presentation also provides FDA guidance related to particle size distribution (PSD) and regulatory considerations for PSD

Working to Address the FDA Critical Path Opportunity for Generic Nasal Spray Suspensions

January 22, 2013 The FDA stated in their 2007 Critical Path Opportunity for Generic Drugs that “If the drug particle size distribution of test and reference products can be demonstrated to be equivalent, then nasal spray suspensions could be treated like nasal spray solutions. The critical path opportunity is to develop methods to measure drug particle size in

Structuring Your Materials Characterization with Raman Spectroscopy

Authors & ContributorsRebekah Byrne June 05, 2014 Do you find you’re not getting the whole picture using your current testing methods to determine a material’s chemistry? Would a complete understanding of a material’s molecular structure aid in the development of a new product or determine the root-cause of a product failure during manufacturing? Incorporating Raman

Spectral Analysis of Materials using Raman Chemical Imaging

Authors & ContributorsRebekah ByrneDavid Exline March 30, 2013 This webinar was designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of various materials, ranging from adhesives and polymers to plastics and glass. During this webinar, our presenters provided an overview of RCI and the type of data that can be generated

Polymorph Analysis Using Raman Chemical Imaging

May 12, 2012 Screening for polymorphs is crucial during drug development, since the crystal form of the active pharmaceutical ingredient (API) directly correlates with its pharmacokinetic properties.  The ability to image and detect spatially variable changes in the drug substance becomes important in determining the drug products efficacy and performance and has significant impact on

Laboratory Methods for Failure Analysis of Pharmaceutical Products

Authors & Contributors Rebekah Byrne David Exline May 09, 2012 Failures in pharmaceutical products may range from issues with delamination and  packaging failures to polymorphs arising in the pharmaceutical product.This webinar is designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This

Evaluation of Pharmaceutical Vials for Glass Delamination

Authors & ContributorsAntonio ScatenaFebruary 04, 2014 Glass delamination can be a costly problem for pharmaceutical drug vial manufactures. For one vial manufacturer glass delamination can cause the recall of thousands of vials of drug product. In this webinar, you will learn about the common types of problems caused by glass delamination in pharmaceutical vials and the

Ensure Quality Inhalation Products with Wear Debris Analysis of Medical Devices

Authors & ContributorsDavid Exline May 16, 2012 Medical devices such as inhalers tend to experience wear debris, which can cause a number of quality issues.  Characteristics of wear debris, including particle size and shape distribution, number of particles and chemistry is important to assess for specific medical devices. This webinar provides an overview of wear