Certara’s Post

'Some of the high-level principles are as follows:   1. The BE study should be performed in healthy subjects unless the drug carries safety concerns that make this approach unethical; 2. The guidance recommends a randomized, single-dose, crossover study design when comparing test and comparator formulations and treatment periods should be separated by a sufficiently long washout period; 3. The test product should originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified. In the case of a production batch smaller than 100,000 units, a full production batch is required; 4. The design of a BE study depends on whether the study is conducted under fasting or fed conditions and the meal type and whether the test product is a non-risk or high-risk product; 5. The BE study report should be written in accordance with ICH E3, Structure and Content of Clinical Study Reports.' If you are planning bioequivalence studies I suggest you look into the latest ICH guidance. #ICH #bioequivalence #drugdevelopment #clinicaltrials

Struggle with challenges in small molecule development? Come learn how particle size and shape analysis can help guide your workflow!

Struggling with data limitations and dead-end leads in your small molecule drug discovery pipeline? Join our exclusive live webinar and discover how the latest updates of AIDDISON software, newly enhanced with GOSTAR's robust databases, empower medicinal chemists to revolutionize their workflows.

Did you checked out a New SCCS Guidance: "THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION"? Updating of animal-free alternative methods: NAM (New Approach Methodology), changes introduced for acute inhalation, skin irritation testing, eye irritation testing with DAL (Defined Approach for eye irritation, Liquid), DASS (Defined Approaches for Skin Sensitisation), new in vitro methods for genotoxicity testing (3D skin Comet; in vitro micronucleus) and many more new interesting things. Check it https://lnkd.in/eT-5qYqB

Changes in USP Pharmacopoeia, Chapter 621 Chromatography Amendments. Read about changing in calculations formula of Resolution, Number of theoretical plates, and signal to noise ratio. #shimadzu #pharmacopia #systemsuitability

Lifotronic: Your Comprehensive HPLC Partner for Every Market GH-900Plus: Cost-effective HbA1c Testing for Clinical Excellence H8: Empowering Mid-Size Labs to Achieve Analytical Preeminence H9: Lifotronix Pioneers HPLC H100: One-Click Versatility for Analytical Mastery H100Plus: Rapid HbA1c Testing with Variant Insight

🔬 Struggling with the challenges of cold chain and storage for diagnostics? Our latest white paper, "The Bead You Need: How Lyophilization is Changing Point-of-Care Diagnostics," reveals how reagent lyophilization can solve common issues in diagnostic testing. By adopting lyophilization, labs can enjoy more reliable and efficient tests without the hassle of strict temperature controls. 📄 Read more about this innovative approach and its benefits for your lab—click the link: https://lnkd.in/eYM9MrrP Sponsored Evik Diagnostic Innovations Inc. #PointOfCare #Lyophilization #EvikDiagnostics

Say No! to water impurities that impact the quality of your laboratory results. Get the MERCK Water Purification system for your laboratory. Call us on 0242287748, 0240907606, and 0245986307, for more information. #medicalequipment #clinicallab #labwater #qualityresults

Flash news! CDRH Announces New Dataset to Aid Chemistry Labs with Chemical Characterization Methods The FDA's Center for Devices and Radiological Health (CDRH) has unveiled a new public dataset to aid chemistry labs in ensuring the robustness of chemical characterization methods used to evaluate the biocompatibility of medical devices. The dataset will assist labs in determining their capability to detect a broad range of potential chemicals. The CDRH plans to expand the dataset and incorporate additional detection methodologies in the future. This initiative is part of CDRH's ongoing commitment to lessen the burden of premarket processes and enhance the consistency and transparency of biocompatibility assessment methods. Check the links in the comments! #medtech #medicaldevice #FDA #biocompatibility #chemicalcharacterization #biosafety #premarketsubmission #regulatory

Transform your research efficiency with the MyGlo™ Reagent Reader — your personal lab partner that fits your budget and your benchtop. No more scheduling conflicts over shared equipment; this low-cost, personal reagent reader integrates seamlessly with CellTiter-Glo® Assays, empowering you to perform #cellviability assays on demand. Ready to enhance your research efficiency? ➡️ https://bit.ly/3SilfOu