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Making data analysis leanSix sigma, process analytical technology (PAT) and related initiatives are driving greater use of statistical analysis methods to increase process understanding and improve manufacturing capabilities.
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The influence of superdisintegrant choice on the rate of drug dissolutionThe addition of superdisintegrants to oral solid dosage forms can improve disintegration and, in turn, drug dissolution.
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Why we need mass serialization — now!Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.
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Can Big Pharma Produce the Next Generation of Medicines?Patent pressures, changing disease profiles, and higher costs force companies to fight for the top.
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Improving the Integrity Test Assurance of Multiround Housings AssessmentsThe authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.
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The role of analytical science in the debate over biosimilarsAs the US biopharmaceutical industry and regulators debate new requirements for biosimilars, industry leaders are turning to analytical science to define intellectual property and business development strategies. Emerging techniques are providing previously unseen protein characterization details, giving both innovator and generics companies new weapons in the battle for future market share.
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Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal ProductThe authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.
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Selecting Lactose for a Capsule-Based Dry Powder InhalerDry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.
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Let's talk the same languageThe potent nature of HPAPIs means there must be careful evaluation of the compound for its level of toxicity when considering manufacture.
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Establishing Material Compatibility, Process Conditions, and Bubble Points of FiltersThe authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined.
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The science behind sorbent selectionDrug products subjected to degradation because of environmental stresses can be salvaged if proper packaging and protection is provided by sorbents.
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Monitoring dissolved ozone in the pharmaceutical industryEmerging technologies now enable continuous on-line monitoring and control of ozone systems, providing precise and reliable results, revolutionizing the way dissolved ozone is measured.
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The new biopharmaceutical blueprintAs a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.
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Current status in buccal drug deliveryThe adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required.
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PVA copolymer: the new coating agentThe use of PVA copolymer-based film can solve the problems associated with lack of film adhesion... to tablets containing large amounts of waxy excipient or a lubricant.
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Quality by Design for analytical methods for use with orally inhaled and nasal drug productsThe design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
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FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based ApproachThe US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.
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Advances in the Regulated Pharmaceutical Use of Dimethyl Sulfoxide USP, Ph.Eur.The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.
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Monitoring Granulation Drying Using Near-Infrared SpectroscopyA novel probe design that reduces the variation in powder-sample density also allows moisture and solvent levels to be accurately modelled and predicted...
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Quality by Design for analytical methods for use with orally inhaled and nasal drug productsThe design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
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Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method TransferThis article presents the findings of PhRMA's annual workshop, held in September 2000, that convened to draft an acceptable analytical practice that would clarify the essential elements of a complete and compliant transfer.
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Current status in buccal drug deliveryThe adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required.
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LCMS-9030 Q-TOF: Effortless performanceThe LCMS-9030 of Shimadzu is a research grade mass spectrometer designed to deliver high-resolution, accurate mass detection with incredibly fast data acquisition rates, allowing scientists to identify and quantify more compounds with greater confidence.
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Innovating Lifecycle Management with Data-Driven and Enabling TechnologiesPharmaceutical companies are developing new strategies to address the ever-increasing development costs for new drug therapies and maximize the value of their existing drug portfolio.
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Supporting critical Phase I–IV clinical studies by outsourcing supporting elementsThe pharmaceutical industry has experienced a number of difficulties during recent years. Greater competition from generics (more than 60% of prescription drugs are supplied from the generic market) and increased gaps in the drug pipeline that result in acquisitions or strategic alliances has led to a feeling of uncertainty in the bio/pharma marketplace. There have also been changes in the marketplace with a shift from primary care to specialty drugs, the introduction of personalized medicine driving the need for biomarker/diagnostic technology and the introduction of biopharmaceuticals.
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20th Anniversary Special Feature: the rise of AsiaRanjit Barshikar, GMP/Quality Consultant and former Vice President of Global Quality for Ranbaxy Laboratories analyses the past, present and future of Asia's pharmaceutical industry. Read more...
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Solid dosage forms from self-emulsifying lipidic formulationsSpraying techniques can be used to produce powder form formulations. The concept works by the adsorption/absorption of a liquid SELF onto a neutral carrier…
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The new biopharmaceutical blueprintAs a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.
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The challenge of 21st century influenzaConventional influenza vaccines use an egg-based culture and harvest process. This is slow and inflexible compared with emerging cell culture-based approaches that respond rapidly to the influenza virus's inherent ability to 'drift' or, more dangerously, 'shift' - a critical factor that would arise in the event of a pandemic.
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Compliance in an Outsource Manufacturing Model: What to Look ForThe authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.
