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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

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The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

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The preferred route of administration for an injected therapeutic agent is subcutaneous (SC), but SC injections are generally limited to no more than 1-2 mL in volume, representing a major challenge, especially for large protein biologics.

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This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

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To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.

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Participants at a Pharmaceutical Research and Manufacturers of America workshop share their views about the acceptable analytical practices of conducting forced degradation studies.

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Integrating EBRs with MES reduces time to market, cuts costs, and enhances compliance performance.

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Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.

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The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.

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Maintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits. Within maintenance, preventive maintenance (PM) is a substantial portion of the budget. Traditionally, PM was an equipment maintenance philosophy based on replacing, overhauling or remanufacturing a piece of equipment at fixed intervals, regardless of its condition at the time. In essence, it involved fixing something that wasn't necessarily broken and this approach is still widely used in the pharmaceutical industry.

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Such an approach inevitably leads to increased front-end costs, but the advantages include better quality, reduced wastage and less product variability.

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FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.

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It will remain to be seen whether pharmaceutical companies will commit lock, stock and barrel to being green.

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The senior director of Oracle's Life Sciences Business Unit tackles some of the technical issues regarding regulatory standardization, software integration, and the trend toward visualization, among other things.

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More than ever, drug makers need to be fleet and flexible-and they need their software to be the same.

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In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

Latest:

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

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This article investigates pharmaceutical applications of terahertz technology, specifically using techniques for solid dosage form analysis such as pulsed spectroscopy (to generate physical information and detect API changes) and pulsed imaging (to locate formulation impurities, and regulate tablet coating quality and thickness).

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How much do you know about parallel trade? Perhaps you may have heard someone mention these words and have then switched off. In a sense, it's hardly surprising given the fact that most media coverage centres on interpretation of complex legal cases. By the time you reach the end of these types of articles, you can't work out what the mentioned companies were arguing about in the first place and on which technical details the case was judged. Yet, time after time, a legal ruling on a parallel trade issue rockets to the front pages of the pharmaceutical press and even, occasionally, the mainstream media.

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Getting a clear view of business performance can be cumbersome, time-consuming and even nigh-on impossible.

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High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest.

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Incorporating quality and economy into downstream purification processes can expedite first-in-human clinical trials, product licensure and technology transfer. Experience in the chromatographic purification of biopharmaceuticals enables the use of downstream processing heuristics to produce target molecules in cost-effective processes suitable for regulatory scrutiny.

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The author analyzes the study design, participation, and data pooling from a recent benchmarking study on pharmaceutical manufacturing and raises concerns about the process used and data collected in evaluating the performance of contract manufacturers.

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When a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.

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One of the major concerns with introducing PAT, however, is that the bias towards process engineering may not ultimately lead to complete control of product quality.

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Solubility of the active pharmaceutical ingredient (API) in an oral formulation is critical for absorption from the gastrointestinal (GI) tract and the intended therapeutic effect. Ensuring that an API has the necessary solubility can be challenging for drug developers and formulators. If limitations in solubility cannot be successfully addressed, a new chemical entity (NCE) is unlikely to advance in the development pipeline. Addressing this potential roadblock to clinical success is becoming increasingly important as NCEs continue to become larger and more lipophilic and, as a result, less soluble.

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Companies that leverage new collaborative technologies in the manufacture, packaging, and distribution of clinical trial materials will be best positioned to reduce their time to market.