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Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing

SGS | 03-Dec-2012 | 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 | 28-Nov-2012 | PDF Insight guide
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical devel...
Smaller pharma companies financially benefitting from CDMO partnerships

Smaller pharma companies financially benefitting from CDMO partnerships

Recipharm AB | 26-Nov-2012 | PDF Case study
In today’s global economy, available financing is increasingly scarce for pharmaceutical companies looking to bring new products to marke...

INFLUENZA TREATMENT CLINICAL TRIALS: CLINICAL CASE STUDIES

SGS | 19-Nov-2012 | PDF Technical / white paper
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview...
Baxter

Lyophilized Pharmaceuticals: A Design Space Approach

Baxter | 29-Oct-2012 | PDF Technical / white paper
This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for...

Extractables & Leachables Risk Assessment

SGS | 22-Oct-2012 | PDF Case study
An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production proces...

Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality

Rho | 06-Dec-2012 | Webinar On-Demand Supplier Webinar
The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-b...

Biosafety Testing: In Vitro Virus Detection

SGS | 09-Oct-2012 | PDF Technical / white paper
Regulatory authorities (US FDA and the EMEA) impose stringent limits on the amount of microbial contaminates and impurities present durin...

Identifying a Differentiated Product – 505(b)(2)

Camargo | 08-Oct-2012 | PDF Data sheet
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential a...

Vetter – Answers that work

Vetter Pharma International GmbH | 03-Oct-2012 | PDF Data sheet
There are many sides to your product’s success. Build them together at Vetter.Whether your injectable is still at the starting line or in...

Identifying the Product

Camargo | 26-Sep-2012 | PDF Technical / white paper
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential a...

Biomarkers of Toxicity Panel in Clinical Trials

ACM Global Central Laboratory | 18-Sep-2012 | PDF Technical / white paper
Most drug candidates are discontinued because of induced organ toxicity and half of them owe this to liver toxicity. This issue explains...

505(b)(2): Fast and Cost-Effective Drug Approval

Camargo | 10-Sep-2012 | PDF Data sheet
Looking to identify a new product for development or improve an existing compound? For lower risk, reduced cost and faster speed to marke...

New Early Phase Concepts: Practical Implementation

SGS | 03-Sep-2012 | PDF Technical / white paper
There is an urgent need to use innovative techniques in early development. This paper will discuss several case studies in which new clin...
Molecular Imaging Inc

Utility of FDG PET in Drug Development

Molecular Imaging Inc. | 20-Aug-2012 | PDF Technical / white paper
Imaging metabolism with FDG PET offers reliable and clinically translatable biomarkers for evaluation of candidate compounds.
Baxter

Lyophilized Pharmaceuticals: A Design Space Approach to Formulation and Process Development

Baxter | 12-Sep-2012 | Webinar On-Demand Supplier Webinar
This webinar will discuss development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design re...
Rho

Targeted Product Development: Personalized Medicine versus Orphan Product Development

Rho | 21-Aug-2012 | Webinar On-Demand Supplier Webinar
The development of therapeutics for personalized medicine leverages many of the advantages of the legislation conferred upon orphan produ...

Connecting Perfectly At Every Stage

Parexel | 30-Jul-2012 | PDF Data sheet
We believe in one bond that's more important than all others. Download our brochure to see how PAREXEL can help to optimize your product...
Enhanced Rheumatoid Arthritis CIA and CAIA Studies

Enhanced Rheumatoid Arthritis CIA and CAIA Studies

Molecular Imaging Inc. | 23-Jul-2012 | PDF Data sheet
Detect disease modification with biomarker imaging using PET, FMT & CT to assess treatment response. Enhance decision...

Vaccine-Based Clinical Trials

SGS | 09-Jul-2012 | PDF Technical / white paper
Download this paper to read two case studies which illustrate strategies for planning and implementing a vaccine-based infectious disease...

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