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Joint Risk Assessment During Technical Transfer – A Framework for Donor and Recipient Companies

Joint Risk Assessment During Technical Transfer – A Framework for Donor and Recipient Companies

Alkermes | 15-Apr-2013 | PDF Case study
Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a uniqu...
Recipharm

RECIPHARM: WHY CONTINUOUS AUDIT READINESS IS CRUICAL

Recipharm AB | 11-Apr-2013 | PDF Application note
Recipharm Stockholm has risen to the challenge of increased regulatory and customer-based inspections by devising an audit system that en...

Increasing Accuracy, Not Costs

METTLER TOLEDO | 04-Apr-2013 | PDF Case study
Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label a...

What Non-statisticians Need to Know about Statistics in Clinical Trials

Rho | 09-May-2013 | Webinar On-Demand Supplier Webinar
Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and ra...

White Paper: Is My Method Still Valid?

SGS | 22-Mar-2013 | PDF Technical / white paper
The goal of method validation is to pro­vide proof that data from each individual sample is indicative of the actual batch content with l...

Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain

Marken | 09-Apr-2013 | Webinar On-Demand Supplier Webinar
2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry Implement clinical developme...

ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms

Aperio | 18-Mar-2013 | PDF Technical / white paper
With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization o...

What Makes 505(b)(2) Different?

Camargo | 14-Mar-2013 | PDF Technical / white paper
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different anima...
Capsugel

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

Capsugel | 26-Feb-2013 | PDF Research study
Traditionally, HPMC capsules have been formulated with secondary gelling agents and ionic gel promoters, which may lead to unwanted issue...
Optimizing your Strategy and Budget for Clinical Trial Supply Distribution

Optimizing your Strategy and Budget for Clinical Trial Supply Distribution

Marken | 20-Mar-2013 | Webinar On-Demand Supplier Webinar
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...
Recipharm

VENDOR MANAGED INVENTORY

Recipharm AB | 08-Feb-2013 | PDF Case study
VENDOR MANAGED INVENTORYCONTINUED GROWTH IN DEMAND FOR VMI Vendor Managed Inventory (VMI) can be defined as a means of optimising su...

New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers

World Courier | 30-Jan-2013 | PDF Technical / white paper
World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel a...

Identifying the Product

Camargo | 04-Feb-2013 | PDF Technical / white paper
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and low...

The Best of Both Worlds: Swiss Quality, Made in China

01-Jan-1970 | Video Video
Lonza brings you the best of both worlds with Swiss quality manufacturing of APIs available at our FDA approved facility in Nansha, China...

Quantify biodistribution, enhance in vivo decisions

Molecular Imaging Inc. | 29-Jan-2013 | PDF Data sheet
Non-invasive preclinical SPECT imaging of test agent biodistribution, kinetics and targeting in discovery and safety applications has key...

Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI

Almac Group | 15-Jan-2013 | PDF Case study
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac...
Working with the cold harsh reality of temperature controlled supply chains

Working with the cold harsh reality of temperature controlled supply chains

Marken | 06-Mar-2013 | Webinar On-Demand Supplier Webinar
What are the regulators telling us? Dealing with a non-harmonized, multi-agency, global challenge.    Monsters Vs, Aliens...
HIGHLY POTENT TECHNICAL TRANSFER AND COMMERCIAL MANUFACTURING

Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company.

Alkermes | 17-Dec-2012 | PDF Case study
As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing se...

Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing

SGS | 01-Jan-1970 | PDF Technical / white paper
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtai...

Analytical Method Development and Validation — A CDMO Perspective

DPT Labs | 20-Nov-2012 | PDF Insight guide
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical devel...

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