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By Business Of Biotech | For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone — Androderm, Augmentin, necitumumab, and Erbitux among them — Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree. |
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| Design Verification Testing Of Combination Products | Article | By Mike Ulman, West Pharmaceutical Services, Inc. | Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification. |
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| Annex 1 Compliance Guidelines For Biological Indicator Users | Article | By Crystal Hostler, Mesa Laboratories | Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators. |
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| Webinar: Regulatory Confidence - Getting the Rheology Right for Generic Topical Pharma Submissions | The process of demonstrating the equivalence of a topical pharmaceutical to a reference listed drug when submitting a new drug application is challenging. This includes facing regulatory affairs personnel when navigating the often-daunting landscape of rheological measurements. In this webinar we explain rheology terminology, core concepts, and show examples of how the required rheology profiles can be generated on high performance rheometers. |
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FOCUS ON ANALYTICS & QUALITY |
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By Bioprocess Online Live | Amy Johnson, Ph.D., VP of Medical Affairs at Vincerx, Sandra Poole, Chief Operating Officer at Mythic Therapeutics, and DeciBio Project Leader Joe Daccache, Ph.D. discuss equipment and manufacturing control conditions, analytical methods release testing, stability testing, and their criticality for IND filing. |
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| The Execution Stage Of Technology Transfer | Article | By Robert Ossig, CAI | What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65. |
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ANALYTICS & QUALITY SOLUTIONS |
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