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1-15 of 159 results
Biovian's Contract Manufacturing of Biopharmaceuticals
| By Biovian
Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals covering services from early development to finished vial.
Contract Research & Services > Contract Research > White Papers
Molnar-Institute: Benefits and Capabilities of DryLab®
| By Molnár-Institute
Anybody working in the realm of HPLC who wishes to economize the resources spent developing and running methods can benefit from the advantages offered by DryLab®.
Contract Research & Services > Contract Research > White Papers
Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D
| By Butterworth Laboratories Ltd
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.
Contract Research & Services > Contract Research > White Papers
DryLab®4 - An Overview
| By Molnár-Institute
Exploring DryLab basics, method development strategy and DryLab benefits.
Contract Research & Services > Contract Research > White Papers
DryLab®4 - Next Generation in HPLC Modeling
| By Molnár-Institute
DryLab® is the leading software solution for HPLC method development, optimization, troubleshooting, robustness testing and training. With less than 12 experimental runs, DryLab® is the only tool capable of delivering over one million precise chromatograms predictions and display the results in its user friendly interface. Its enhanced features will transform your chaotic method development into a comfortable and streamlined workflow, as well as increasing your productivity.
Contract Research & Services > Contract Research > White Papers
Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling
| By Molnár-Institute
The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.
Contract Research & Services > Contract Research > White Papers
Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD
| By Butterworth Laboratories Ltd
In recent times there has been a large increase in the type and number of products packaged using Modified Atmosphere Packaging (MAP) procedures. The majority of these processes concern the removal of oxygen from packaging systems in order to reduce oxidative degradation of the product and increase shelf life. Whilst most of the historical development of MAP took place within the food industry, over the last 20 years there has been a large growth in its application within the pharmaceutical sector.
Contract Research & Services > Contract Research > White Papers
Sciences Radiolabelling Brochure
| By Almac
Trust Almac with your 14C radiolabelling requirements and we will offer advice on the most appropriate label position for your molecule, including synthetic feasibility and metabolic stability.
Contract Research & Services > Contract Research > White Papers
Commerical Packaging
| By Almac
- Complementary US and UK operations, - Quality-driven, flexible packaging solutions, - Market leader for product launch of niche / orphan drug products, - Solid oral dose and biopharmaceutical packaging, - Packaging and artwork design, - Full serialisation and 2D matrix barcoding solutions.
Contract Research & Services > Contract Research > White Papers
Providing an Unparalleled Range of Contract Pharmaceutical Development and Manufacturing Services Globally for Over 40 Years
| By Almac
Only we can combine the expertise from our range of specialised services to provide you with the right solutions to help you develop and commercialise your products.
Contract Research & Services > Contract Research > White Papers
Building the Next Generation IRT: An Exclusive Look Under the Hood of IXRS®3
| By Almac
Interactive Response Technology (IRT) systems - used to manage patient interactions and drug supplies during clinical trials - perform a range of functions for sponsors, drug depots, and investigative sites. Yet, they are typically viewed by sponsors as a "painful necessity" rather than as a welcome, invaluable tool. That perception exists because the underlying technology is outmoded, and the user's experience is stuck in the pre-Internet era. While established systems are "tried and true" in that they have supported thousands of clinical trials over the years, they can also be tired and cumbersome.
Contract Research & Services > Contract Research > White Papers
Introducing Direct to Patient Shipments
| By Almac
Almac will ship the Clinical Trial Material (CTM) to participating clinical sites, where the drug is to be stored. Both shipping and storage of the CTM will follow standard procedures. Sites will interact with the Interactive Response Technology (IRT) provider in the usual way to obtain a kit assignment.
Contract Research & Services > Contract Research > White Papers
Bioanalysis of Biosimilars
| By PRA Health Sciences
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. Immunogenicity assays are used to determine and further characterize any anti-drug antibodies (ADA) formed during these studies. These analytical methods are pivotal for establishing similarity of biosimilar products as compared to their reference compounds.
Contract Research & Services > Contract Research > White Papers
ECG Assessments During the Development of Oncology Compounds
| By PRA Health Sciences
Assessment of ECGs during the development of oncology compounds is challenging. Toxicity of these compounds often precludes the inclusion of healthy volunteers while a higher variability of ECG parameters in oncology patients can be expected due to disease, comedication, and co-morbidities. Recently, it was shown that the extraction of ECG data using the High Precision QT technique of iCardiac and Exposure Response analysis can result in a conclusive ECG assessment with a limited number of volunteers. Applying these techniques in a small-sized oncology study with dedicated PRA staff presents a unique opportunity for a conclusive and efficient cardiac safety assessment by ECG.
Contract Research & Services > Contract Research > White Papers
1-15 of 159 results