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Library > Technical Papers

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...
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...
Vetter Pharma

Meeting the challenges of complex drug substances

Vetter Pharma International GmbH | 29-Aug-2013 | PDF Technical / white paper
Realizing the full potential of an injectable drug compound is no small task. In the months and years that lead from the discovery phase...

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...

(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,...
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...

Forecasting strategies to optimize clinical trials

Almac Group | 21-Jun-2013 | PDF Technical / white paper
In a market that is constantly evolving, where rising complexities and costs associated with product development and clinical trial condu...
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...