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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...
Download now!Data sheet

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?
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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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Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain - Marken

25-Mar-2013 - 2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry Implement clinical development methodologies for quality, relationships, and performance Strategies to optimize drug development to reduce global trial time and costs
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What Makes 505(b)(2) Different? - Camargo

19-Mar-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...
Download now!Research study

Vcaps® Plus capsules: The next generation HPMC capsule for optimum formulation of Pharmaceutical Dosage forms - Capsugel

28-Feb-2013 - Traditionally, HPMC capsules have been formulated with secondary gelling agents and ionic gel promoters, which may lead to unwanted issues during the product development.Vcaps® Plus HPMC capsules are made through a proprietary manufacturing process that eliminates the need for gelling...
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Optimizing your Strategy and Budget for Clinical Trial Supply Distribution - Marken

20-Feb-2013 - How to determine if a depot or direct to site shipments are more efficient Calculation based on a case study How to avoid delays and assure that your shipments arrives without delays and excursions

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