Library > All Products
Technical / white paper
Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier
01-Jan-2013 -
WORLD COURIER is the market leader in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge of the local regulatory environment,...
Case study
Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company. - Alkermes
18-Dec-2012 -
As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market. This case study demonstrates how a commercial manufacturing partnership...
Technical / white paper
Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing - SGS
03-Dec-2012 -
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtain results that accurately represent the sterility status of a batch. Download this article for the best practices
Insight guide
Analytical Method Development and Validation — A CDMO Perspective - DPT Labs
28-Nov-2012 -
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug...
Case study
Smaller pharma companies financially benefitting from CDMO partnerships - Recipharm AB
26-Nov-2012 -
In today’s global economy, available financing is increasingly scarce for pharmaceutical companies looking to bring new products to market. Find out how risk-sharing practices initiated by Recipharm have made it possible for customers to closely collaborate and share rewards as...
Technical / white paper
INFLUENZA TREATMENT CLINICAL TRIALS: CLINICAL CASE STUDIES - SGS
19-Nov-2012 -
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges faced when conducting an influenza treatment study based on two recently managed clinical trials.
Technical / white paper
Lyophilized Pharmaceuticals: A Design Space Approach - Baxter
29-Oct-2012 -
This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm.
Case study
Extractables & Leachables Risk Assessment - SGS
22-Oct-2012 -
An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European manufacturing plant for 40 finished products, resulting in a global testing plan.
On-Demand Supplier Webinar
Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho
15-Oct-2012 -
The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools...
Technical / white paper
Biosafety Testing: In Vitro Virus Detection - SGS
09-Oct-2012 -
Regulatory authorities (US FDA and the EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines and vaccines.One area of concern is that the cell substrates used in the production of...
Data sheet
Identifying a Differentiated Product – 505(b)(2) - Camargo
08-Oct-2012 -
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential and lower risk. Camargo offers a clear process to identify products that have documented market differentiation.
Data sheet
Vetter – Answers that work - Vetter Pharma International GmbH
03-Oct-2012 -
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 full-scale production, there are possibilities all around you. Thoughtful questions that can open new doors. Precisely planned processes that...
Technical / white paper
Identifying the Product - Camargo
26-Sep-2012 -
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process to identify products that have documented market differentiation:
Selection criteria
Identify, assess and...
Technical / white paper
Biomarkers of Toxicity Panel in Clinical Trials - ACM Global Central Lab
18-Sep-2012 -
Most drug candidates are discontinued because of induced organ toxicity and half of them owe this to liver toxicity. This issue explains why drug developers need to be aware of the latest options for liver and kidney laboratory safety testing,...
Data sheet
505(b)(2): Fast and Cost-Effective Drug Approval - Camargo
10-Sep-2012 -
Looking to identify a new product for development or improve an existing compound? For lower risk, reduced cost and faster speed to market, Camargo Pharmaceutical Services is your go-to expert in the 505(b)(2) pathway. Find out if 505(b)(2) is for...
Technical / white paper
New Early Phase Concepts: Practical Implementation - SGS
03-Sep-2012 -
There is an urgent need to use innovative techniques in early development. This paper will discuss several case studies in which new clinical trial methods were employed during the early phase clinical development of therapeutic compounds.
Technical / white paper
Utility of FDG PET in Drug Development - Molecular Imaging Inc.
20-Aug-2012 -
Imaging metabolism with FDG PET offers reliable and clinically translatable biomarkers for evaluation of candidate compounds.
On-Demand Supplier Webinar
Lyophilized Pharmaceuticals: A Design Space Approach to Formulation and Process Development - Baxter
09-Aug-2012 -
This webinar will discuss development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm. Steven Nail, PhD, principal scientist at Baxter’s Lyophilization Center of Excellence with extensive expertise in the field, presents...
On-Demand Supplier Webinar
Targeted Product Development: Personalized Medicine versus Orphan Product Development - Rho
31-Jul-2012 -
The development of therapeutics for personalized medicine leverages many of the advantages of the legislation conferred upon orphan products. New products must be positioned intelligently to take advantage of this legislation. Join David Shoemaker, Ph.D. as he discusses the benefits...
Data sheet
Connecting Perfectly At Every Stage - Parexel
30-Jul-2012 -
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 value.