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Data sheet
505(b)(2): It’s A Different Animal - Camargo
13-May-2013 -
505(b)(2) is more than just a regulatory pathway, it is a distinctly different animal — a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. Find out if 505(b)(2)...
Live 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...
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?
Case study
A risk assessment framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with the technical transfer of pharmaceutical product - 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...
Application note
RECIPHARM: WHY CONTINUOUS AUDIT READINESS IS CRUICAL - Recipharm AB
15-Apr-2013 -
Recipharm Stockholm has risen to the challenge of increased regulatory and customer-based inspections by devising an audit system that enables the company to be in a state of continuous inspection readiness. Recipharm, one of the busiest and most highly regarded...
Case study
Increasing Accuracy, Not Costs - Mettler Toledo
11-Apr-2013 -
Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label and packaging defects from retailer shelves. One major pharmaceutical manufacturer came to Mettler-Toledo CI-Vision hoping to reduce the rate of defective...
On-Demand Supplier Webinar
What Non-statisticians Need to Know about Statistics in Clinical Trials - Rho
04-Apr-2013 -
Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions.
Technical / white paper
White Paper: Is My Method Still Valid? - SGS
26-Mar-2013 -
The goal of method validation is to provide proof that data from each individual sample is indicative of the actual batch content with little deviation. This paper outlines the importance of validation as well as the official requirements, including characteristics...
On-Demand Supplier Webinar
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
Technical / white paper
ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms - Aperio
20-Mar-2013 -
With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant that slides had to be packed, shipped and tracked. Often the reading pathologist was required to...
Technical / white paper
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...
On-Demand Supplier Webinar
Working with the cold harsh reality of temperature controlled supply chains - Marken
06-Mar-2013 -
What are the regulators telling us?
Dealing with a non-harmonized, multi-agency, global challenge.
Monsters Vs, Aliens
How to navigate the maze of import & export regulators.
Thinking beyond the box!
Packaging selection – A different horse for every course
Validation & Qualification – Where are...
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...
On-Demand Supplier Webinar
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
Case study
VENDOR MANAGED INVENTORY - Recipharm AB
11-Feb-2013 -
VENDOR MANAGED INVENTORYCONTINUED GROWTH IN DEMAND FOR VMI Vendor Managed Inventory (VMI) can be defined as a means of optimising supply chain performance in which a chosen outsourced manufacturer partner is responsible for maintaining their customer’s inventory levels. The manufacturer has...
Technical / white paper
New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers - World Courier
11-Feb-2013 -
World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel and infrastructure closer to key customers in Switzerland and Austria with the recent opening of offices in Basel and Innsbruck.At the same...
Technical / white paper
Identifying the Product - Camargo
06-Feb-2013 -
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process from concept through commercialization to identify products with documented market differentiation:
Selection...
Video
The Best of Both Worlds: Swiss Quality, Made in China - Lonza
05-Feb-2013 -
Lonza brings you the best of both worlds with Swiss quality manufacturing of APIs available at our FDA approved facility in Nansha, China. From backward integration to tailored production concepts for efficient manufacturing, Lonza offers sustainable solutions for regionally important...
Data sheet
Quantify biodistribution, enhance in vivo decisions - Molecular Imaging Inc.
04-Feb-2013 -
Non-invasive preclinical SPECT imaging of test agent biodistribution, kinetics and targeting in discovery and safety applications has key advantages over pre-existing methods including:
full 3-dimensionality with tissue and sub-tissue localization
fine kinetics, targeting, binding and clearance pathways can be examined
clinical translatability
isotope multiplexing...
Case study
Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group
21-Jan-2013 -
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...