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Baxter

Pharmaceutical Development for ADCs

Baxter | 31-Jul-2013 | PDF Case study
Formulation, process, and analytical development for ADCs is complex. While an aqueous solution formulation may be preferred over a lyop...
Recipharm

Creating and capturing value for outsourcing pharmaceutical manufacturing

Recipharm AB | 09-Jul-2013 | PDF Case study
An efficient technology transfer process can create value as well as capture it for pharmaceutical companies and CMOs alike.Discover the...
Capsugel

Accelerating Lipid Drug Formulation with the Premier Expert System

Capsugel | 09-Jul-2013 | PDF Case study
Formulation scientists are increasingly pivotal to pharmaceutical product development. They are often faced with the daunting challenge o...
ACM Global

Endpoint Based Protocol Development: A Central Laboratory Perspective

ACM Global Central Laboratory | 19-Jun-2013 | PDF Technical / white paper
The ability to ensure that relevant and accurate laboratory testing is performed, which will meet the primary and secondary endpoints in...
Mettler Toledo CI-Vision

Avoid Angry Customers-Eliminate Defects

Mettler Toledo | 06-Jun-2013 | PDF Technical / white paper
In the pharmaceutical business, it is crucial that containers be free of contamination, formation defects and dimensional irregularities...

Understanding the 505(b)(2) Approval Pathway

Camargo | 06-Jun-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...

Conversion of Legacy Data to CDISC

SGS | 29-May-2013 | PDF Technical / white paper
Legacy data submitted to the FDA should be in a standardized format. This article is a summary of the FDA´s recommendations to approach t...

505(b)(2): It’s A Different Animal

Camargo | 09-May-2013 | PDF Data sheet
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,...
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...

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...

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...
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...

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...