Analysis of Pharmaceutical Raw Materials Through Packaging Using an FT-NIR Fiber Optic Probe

| November 28, 2018

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The analysis of all incoming pharmaceutical raw materials is key part of 21CFR compliance.  It is therefore important to have a high-throughput method by which raw materials may be analyzed, while also preventing sample exposure. This application note explores the analysis and identification of various commonplace pharmaceutical raw materials through both one and two layers of clear polyethylene bags using the PerkinElmer Spectrum Two N Remote Sampling Module and Spectrum Touch Software.

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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The Future of Pharma Beyond Blockbusters

Article | April 20, 2021

We’ve all heard the saying “treat the patient, not the disease”, and this couldn’t be truer in today’s ever-changing pharmaceutical landscape. We are living in a time of revolution – advancements in genomics and technology are improving our ability to develop precise drugs and targeted therapies, rather than focusing on a one size fits all approach. Each individual’s genetic makeup is slightly different from everyone else’s,

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Clinical Supply Availability & Speed to Study Start-Up

Article | April 20, 2021

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

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3 Big Pharma Stocks Plunging the Most During the Coronavirus Stock Market Crash: Are They Buys?

Article | April 20, 2021

Big pharma stocks have been clobbered during the coronavirus-caused stock market crash. You can count the number of drugmakers with market caps of $25 billion or more whose shares haven't dropped by double-digit percentages on one hand -- and have several fingers left over. Three big pharma stocks have plunged the most: AbbVie (NYSE:ABBV), Bristol Myers Squibb (NYSE:BMY), and Pfizer (NYSE:PFE). But are these stocks smart picks to buy right now?

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Spotlight

Bayer

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation, growth and high earning power.

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