Authors
Latest:
LC–MS/MS method for the determination of Vitamin D3 in human plasmaAn LC–MS/MS method for the quantitative determination of vitamin D3 in human plasma has been developed and validated with positive atmospheric chemical ionization sources.
Latest:
Bioanalysis of recombinant proteins by mass spectrometryBiotechnological developments have led to an increased number of recombinant proteins or antibodies in drug development that offer high potential in various diseases, such as cancer, growth disturbances and diabetes.
Latest:
Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part 1: Survey MethodologyDuring autumn 2001, a Delphi survey was conducted using the Internet to discover the opinions of European experts from the pharmaceutical fields of industry, regulation and academia regarding pharmaceutical process validation. The Internet Delphi method was found to be an appropriate tool for exploring the opinions and experiences of pharmaceutical manufacturing because it allowed anonymous participation and discussion between geographically dispersed parties. However, to obtain reliable results, many factors were taken into account, as this article examines.
Latest:
Upcoming technologies to facilitate more efficient biologics manufacturingThe number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.
Latest:
Zebrafish: a multifaceted approach for drug safety assessmentMany compounds fail in preclinical development because of safety-related problems, but identifying 'predictable' safety or toxicity liabilities earlier in the process could lead to improved design and selection of compounds that are more likely to be approved.
Latest:
Spherical Crystallization for Lean Solid-Dosage Manufacturing (Part II)In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.
Latest:
Upcoming technologies to facilitate more efficient biologics manufacturingThe number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.
Latest:
Learning from Lean SigmaLean Sigma approaches can reduce waste, cost, cycle time and variability in outputs.
Latest:
Hot-melt extrusion: an emerging drug delivery technologyHot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.
Latest:
Orally disintegrating tablets: the path to improved patient compliance and enhanced life cycle managementOrally disintegrating tablets offer numerous advantages compared with traditional tablets and capsules, and can be an effective solution for developing line extensions of currently marketed therapies.
Latest:
Qualification of a Chromotographic ColumnIn this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.
Latest:
Pharmaceutical packaging and labelling for blind and partially sighted peopleA European Commission directive requires suppliers to incorporate information on medicines in formats suitable for blind and partially sighted people, although the associated standard has not been introduced yet. This article looks at some of the issues that will need to be addressed when the standard is adopted.
Latest:
Procedures: Improving Their QualityA procedures system must be well designed and managed to be effective and efficient.
Latest:
Serialisation, Aggregation and AuthenticationPharmaceutical manufacturers will be-and are already&mdashfacing enormous challenges to implement the serialization regulations within the given timeframe.
Latest:
Developments in particle engineering processes for pharmaceutical drug delivery systemsOne 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.
Latest:
Enhancing Topical Delivery Using ProdrugsThe permeation of drugs through the skin is compromised by the presence of polar functional groups such as thiols, alcohols, phenols, imides or amides. By transiently masking these polar functional groups as prodrugs the permeability of drugs containing these functional groups through the skin can be improved.
Latest:
Enhancing Topical Delivery Using ProdrugsThe permeation of drugs through the skin is compromised by the presence of polar functional groups such as thiols, alcohols, phenols, imides or amides. By transiently masking these polar functional groups as prodrugs the permeability of drugs containing these functional groups through the skin can be improved.
Latest:
Predicting powder flowPredicting the flow characteristics of powders during manufacture is especially important for the pharmaceutical engineer. Getting the powder flow wrong can be highly disruptive to plant performance and productivity, particularly where equipment has to be taken off-line and stripped down for cleaning out blockages. The flow behaviour of the individual ingredients may be well known, but as these are blended and reacted their flow properties can change.
Latest:
Dry powder inhalers: challenges and goals for next generation therapiesThere have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.
Latest:
A guide to EFPIA's Mock P.2 documentEFPIA'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:
Economy by designIncorporating 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.
Latest:
Designing a globally acceptable registration stability protocolLarge stability studies for drug products and devices with multiple strengths, packaging configurations and orientations can cost millions of dollars for the analytical testing alone.
Latest:
Centre of attractionThe pharmaceutical industry in Asia is gearing up to be at the centre of the global market. Most pharmaceutical companies in the region expect this shift to happen fast. Not only is Asia set to become the largest pharmaceutical market in the world, but many Asian territories will be the powerhouses of the industry. By 2020, the worldwide pharmaceuticals market could be worth around $1.3 trillion, with China being the second or third biggest market.
Latest:
Science and innovation is the UK's futureUK science has an outstanding record and we remain strong internationally in terms of achievement, productivity and efficiency.
Latest:
The effect of storage conditions on the physical stability of tabletsWater interacts with pharmaceutical solids at virtually all stages of manufacture, from synthesis of raw materials to the storage of the final dosage form. The interactions of water with powders is, therefore, a major factor in the formulation, processing and product performance of solid pharmaceutical dosage forms.
Latest:
Selecting the Right Ultrafiltration Membrane for Biopharmaceutical ApplicationsUltrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.
Latest:
Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Latest:
Oman pharma wins European approvalWhile the Gulf region has already become well-known for its globally accepted infrastructure, and large projects in tourism and other service areas, major investments in healthcare or pharmaceuticals have failed to develop as well.
