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Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection - ACM Global Central Laboratory

17-Jun-2014 - Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected and treated. The key risk factors of metabolic syndrome were identified approximately 250 years ago. However, there...
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Are there Any Markets left to Emerge? - World Courier

02-Jun-2014 - North America, Western Europe and—to a lesser extent—Australasia once served as prime locations for the majority of research. But these Western markets are approaching saturation, which has led to a lack of naive patients who are available and willing to...
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Excipients for Multilayer Tablets - JRS PHARMA LP

07-May-2014 - Multi-layered tablets bring together differently formulated powder mixtures, which typically contain different APIs, into a single tablet with two or more layers. They offer benefits for overcoming API-API interactions and stability issues, tailoring dissolution profiles, and bringing brand recognition to...
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Fast and Flexible – Early Phase Manufacturing - Patheon Inc

05-May-2014 - Early-stage manufacturers of oral solid dosage forms need to be fast and flexible to generate development pathways that can cope with variable API characteristics as well as highly potent molecules. Technology, risk assessment, Quality by Design and scale up are...
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Meeting the challenges of complex drug substances - Vetter Pharma International GmbH

15-Apr-2014 - Realizing the full potential of an injectable drug compound is no small task. In the months and years that lead from the discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can slow development...
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White Paper: Model-Based Drug Development - SGS Life Science Services

14-Apr-2014 - In this white paper learn how MBDD can help you make better drug development decisions through the use of mathematical models. Read how such models can be applied to population pharmacokinetics, dose-response characterization, and pediatrics. 
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Dow AFFINISOL™ polymers for Solubility Enhancement - Dow Pharma & Food Solutions

12-Mar-2014 - Dow’s AFFINISOL™ line of excipients include AFFINISOL™ HMPCAS for spray drying applications and AFFINISOL™ HPMC for hot melt extrusion (HME) applications. Hypromellose acetate succinate (HPMCAS) has proven effective at producing stable amorphous solid dispersions for poorly soluble APIs. We will highlight: •...
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How glass-forming polymers improve bioavailability / Enhanced oral bioavailability with Soluplus® – case study - BASF SE

12-Mar-2014 - How glass-forming polymers improve bioavailabilityPolymers are essential components of oral solid dosage forms and used as binders, disintegrants or coatings. Given the increase in poorly water-soluble drugs, not only well-known but also specifically designed polymers (e.g. Soluplus®) can be used...
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Role of excipients in design of solid amorphous drug dispersions for delivery of poorly water-soluble drugs - Ashland

10-Mar-2014 - Most new drug candidates suffer from poor water- solubility leading to rate limiting dissolution, slow absorption and limited bioavailability. Solid amorphous drug dispersions are most commonly used improve bioavailability by enhancing drug solubility. The selection of the right solid dispersion...
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Controlled Release and Bioavailability Enhancement -

28-Oct-2013 - Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Customized Controlled Release Drug Delivery •    Bioavailability Enhancement •    Taste Masking (liquid and solid presentations)When applied appropriately, these technologies can deliver therapeutic and convenience benefits to...
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505(b)(2): 10 Years and Running with 300+ Approvals - Camargo

21-Oct-2013 - In 2003, the FDA unleashed the 505(b)(2) pathway. With a record 47 approvals in 2012, the pathway is helping product developers secure up to 7 years of market exclusivity.Visit us at AAPS booth 4304 and read our white paper to learn more.
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New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy - Baxter

17-Oct-2013 - Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation,...
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(b)(2) or not (b)(2)? That is the question. - Camargo

19-Aug-2013 - 505(b)(2) is more than a regulatory pathway - for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. So, is (b)(2) for you? To find out...
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Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials - Marken

07-Aug-2013 - Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider a DTP solution. Included in the discussion are concerns with the traditional distribution channels, advantages and challenges...
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Pharmaceutical Development for ADCs - Baxter

05-Aug-2013 - Formulation, process, and analytical development for ADCs is complex. While an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution...
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Accelerating Lipid Drug Formulation with the Premier Expert System - Capsugel

11-Jul-2013 - Formulation scientists are increasingly pivotal to pharmaceutical product development. They are often faced with the daunting challenge of identifying the most suitable drug delivery platform among a myriad of options and developing and validating robust systems that address the challenges...
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Understanding the 505(b)(2) Approval Pathway - Camargo

11-Jun-2013 - When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
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505(b)(2): It’s A Different Animal - Camargo

13-May-2013 - 505(b)(2) is more than a regulatory pathway — for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. So, is (b)(2) for you?
Watch now!On-Demand Supplier Webinar

Supply Chain Issues and Trends in Asia - Marken

02-May-2013 - Import/export of biological samples from China China: Large Pharma Reverse Logistics A Common Issue: Destruction of Drug in Taiwan J-GMP: How is GMP different in Japan? Korea: Biosimilars Hotbed India: Will Regulations Change to Allow Quicker Study Approval in 2013?
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Joint Risk Assessment During Technical Transfer – A Framework for Donor and Recipient Companies - Alkermes

22-Apr-2013 - Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...

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