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Transdermal Delivery Systems - QPS

01-May-2014 - Whereas dermatologic topical formulations (foams, creams, lotions, ointments, gels, etc.) target skin diseases, topical transdermal delivery systems (TDDS) are designed to treat systemic medical conditions or localized joint or muscle conditions, using the skin as the route of drug delivery....
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Veristat and Karyopharm Therapeutics Inc. Agreement - Veristat, LLC

20-Jun-2014 - HOLLISTON, Mass. – June 15, 2014 – Veristat, a full service Contract Research Organization, announced today that Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets...
Download now!Clinical study

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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Industry leading titers of protein in E.coli - Fujifilm

26-May-2014 - The development of large scale E. coli expression systems can be rate limiting in process development.  Fujifilm's pAVEway™ system combines innovative vector technology with platform fermentation processes to rapidly delivers industry leading titers.
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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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The Promise and Challenge of Adaptive Design: Oncology Trials - Medpace

05-May-2014 - Incorporating adaptive design methodologies into clinical trials can reduce costs while maintaining trial integrity.  Learn how these design strategies can improve the effectiveness and efficiency of oncology studies
Download now!Data sheet

Orthotopic Brain Tumor Models Improved with Imaging - Molecular Imaging Inc.

14-Apr-2014 - Know more: enhance in vivo pharmacology with imaging. Recent tumor model development and informative imaging technologies have enabled the efficient and robust use of orthotopic models. These models have proven to be the most clinically relevant and predictive cancer models....
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Forecasting strategies to optimize clinical trials - Almac Group

03-Mar-2014 - In a market that is constantly evolving, where rising complexities and costs associated with product development and clinical trial conduct present new clinical supply chain challenges, conventional forecasting methods may not provide an adequate solution.  Add to this the increasing...
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Applying a Health- and Science- based Risk Assessment for Multi-Product Biologics manufacturing - Fujifilm

18-Nov-2013 - Over the last 10-15 years, it has become common practice to manufacture biologics intended for clinical trials (Investigational Medicinal Products, or IMPs) in multi-purpose facilities.This flexibility has been a key enabler in ensuring a flow of novel products, frequently targeting...
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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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HEPATITS C VIRUS – RACE FOR TREATMENT - SGS

23-Sep-2013 - To understand why there is so much buzz in the pharmaceutical world for a better HCV treat­ment, as with most things, you have to start with history. This article will highlight the history, why there is a growing need for...
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Patient Reminders: Improve Retention & Compliance - Cenduit

02-Sep-2013 - The average cost of a patient lost to follow-up is $5,000.  Read on to learn how to incorporate patient reminders into your protocol to reduce cost and resource wastage associated with patient noncompliance and early withdrawal. 
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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...
Download now!Case study

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?
Watch now!On-Demand Supplier Webinar

Antibody Drug Conjugate Development and Manufacture - Piramal

03-May-2013 - With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...
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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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