Outsourced Pharma Editorial
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Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
4/16/2024
Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.
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A Good Feeling ($$) About Contract Manufacturing
4/15/2024
Occasionally, we look at revenue numbers assigned to the collective activities we focus on at Outsourced Pharma: drug development and manufacturing outsourcing, and working with CDMOs. And we also can provide some pep talks, too.
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You Want To Rein In China? Then Actually Do It
4/12/2024
Chief Editor Louis Garguilo takes a hard look at proposed legislation H.R. 7085 - the BIOSECURE Act - and draws out some interesting angles and conclusions regarding the biopharma battle between the U.S. and China.
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Cell Counting Is Growing More Important Amid Advanced Therapy’s Rise
4/12/2024
You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.
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AI Is Unearthing New Drug Candidates, But It Still Needs Human Oversight
4/11/2024
AI can accelerate timetables and minimize wasted resources by analyzing vast amounts of data, but human oversight is necessary to address the limitations and biases of AI systems.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
4/10/2024
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
4/9/2024
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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Stop Fixating On CDMO Pricing!
4/8/2024
You may have an ill-advised idée fixe on the prices your CDMO is charging you. Who says? Among others, members of our Outsourced Pharma Editorial Advisory Board – a practical and practiced assembly of successful outsourcing professionals. And they start with an offensive C-suite.
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Digitizing CMC Knowledge Management
4/8/2024
Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.
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Managing Supply Chain Risks Using Relational Risk Analysis
4/5/2024
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.