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New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy

Baxter | 19-Nov-2013 | Webinar On-Demand Supplier Webinar
Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been deve...

Making a safe choice for the manufacture of hormones

Recipharm AB | 11-Oct-2013 | PDF Case study
As consumer demand for hormones increases worldwide, and formulations for manufacturing advance from microgram to milligram levels, what...
Marken

Trade Compliance and Pharma: What you need to know about the trade aspects of your global studies

Marken | 15-Oct-2013 | Webinar On-Demand Supplier Webinar
This webinar will explore the basics of trade compliance for pharmaceutical products: Overview of global trade compliance Trade compli...
sgs

Nucleic Acid Amplification Technique for Biosafety

SGS Life Science Services | 02-Sep-2013 | PDF Technical / white paper
Use of cutting-edge NATs reduces the amount of time needed for development and safety testing of novel biotech products. This white paper...

Clinical Document distribution - Secure and Automated

PharmaSOL | 17-Sep-2013 | PDF Case study
psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user s...
SGS

HEPATITS C VIRUS – RACE FOR TREATMENT

SGS | 20-Sep-2013 | PDF Technical / white paper
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 w...

Patient Reminders: Improve Retention & Compliance

Cenduit | 02-Sep-2013 | PDF Technical / white paper
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...

Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis

SGS Life Science Services | 09-Oct-2013 | Webinar On-Demand Supplier Webinar
2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Corr...

(b)(2) or not (b)(2)? That is the question.

Camargo | 14-Aug-2013 | PDF Technical / white paper
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,...

Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials

Marken | 10-Sep-2013 | Webinar On-Demand Supplier Webinar
Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reaso...
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,...

Antibody Drug Conjugate Development and Manufacture

Piramal | 24-May-2013 | Webinar On-Demand Supplier Webinar
With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs...
Marken

Supply Chain Issues and Trends in Asia

Marken | 15-May-2013 | Webinar On-Demand Supplier Webinar
Import/export of biological samples from China China: Large Pharma Reverse Logistics A Common Issue: Destruction of Drug in Taiwan...