Library > Technical Papers
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.
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.
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.
Data sheet
Enhanced Rheumatoid Arthritis CIA and CAIA Studies - Molecular Imaging Inc.
23-Jul-2012 -
Detect disease modification with biomarker imaging using PET, FMT & CT to assess treatment response. Enhance decision making with
complementary end points
minimized histopathology
Improve your next RA Study–contact us at marketing@molecularimaging.com
Technical / white paper
Vaccine-Based Clinical Trials - SGS
09-Jul-2012 -
Download this paper to read two case studies which illustrate strategies for planning and implementing a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
Technical / white paper
The new product development reality - Parexel
25-Jun-2012 -
While winning FDA or other regulatory approval is a formidable hurdle, it is no longer the end game when it comes to defining if the development of a product is truly successful. In today's health care reality, the new finish...
Data sheet
505(b)(2): Fast and Cost-Effective Drug Approval - Camargo
20-Jun-2012 -
Looking to embark on a 505(b)(2) product approval?More products than ever are approved via the 505(b)(2) pathway — a fast and cost-effective route for drug approval. With global reach across 26 countries, Camargo Pharmaceutical Services executes 505(b)(2) drug development programs...
Technical / white paper
Pharmaceutical Outsourcing - key success factors - Alkermes
13-Jun-2012 -
It is now considered a sound strategic move by pharmaceutical companies, from big pharma to smaller players, to increasingly rely on outsourcing service providers to fulfil specific tasks, solve problems, and improve efficiency and productivity.While engaging in an outsourcing solution...
Data sheet
505(b)(2): Fast and Cost-Effective Drug Approval - Camargo
28-May-2012 -
As a fast and cost-effective route for drug approval, more products than ever are approved via the 505(b)(2) pathway. Camargo Pharmaceutical Services is your go-to expert for 505(b)(2) approvals that provide product differentiation and a period of market exclusivity.
Data sheet
Effective Controlled Substances Supply Chain Management - DPT Labs
23-May-2012 -
At a time when supply chain management has become increasingly complex, managing the unique challenges of the controlled substance supply chain can seem daunting for companies lacking in‐house capabilities and resources. Effective management of the controlled substance supply chain and...
Technical / white paper
Implementing LEAN Techniques in Quality Control - Baxter
17-Apr-2012 -
Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Baxter’s contract manufacturing facility in Halle/Westfalen, Germany, has been applying LEAN techniques since 2007 with the goal of reducing release lead times....
Technical / white paper
A Clinical Perspective on IV Medication Delivery - Baxter
09-Apr-2012 -
Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists. The information provided reflects research conducted assessing medication delivery practices and preferences.
Technical / white paper
Sample Prep Proposed USP<233> Elemental Impurities - SGS
27-Feb-2012 -
Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.