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| home > white papers > Overcoming research challenges with Adaptive Trials - PCI Pharma Services |
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 WHITE PAPERS |
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PCI Pharma Services
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Overcoming research challenges with Adaptive Trials
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There has been cause for concern within the pharmaceutical industry over
the last five years, regarding increasing research and development
costs, combined with a fall in the number of new drugs brought to
market. In an attempt to overcome this issue there has been a
significant rise in the use of adaptive clinical trial designs, whilst
saving time and money as well as facilitating more effective decision
making. One of the biggest challenges that pharmaceutical companies have
experienced has been delivering compliant clinical trials supplies
across diverse patient populations in the relatively short timeframes
that adaptive trial designs require, remaining focused on ensuring that
patient compliance and product quality is in no way compromised. This
demand has led to the launch of fast response services that support
Research and Development in responding to changing dosing regimens
mid-trial.
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News and Press Releases |
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Merck Launches ADC ExpressTM Services to Accelerate Pre-clinical Conjugation Candidate Selection
• Provides rapid production of antibody drug conjugates (ADCs) for best candidate selection
• Established platform technology to reliably scale target molecules
• Reduces time to clinic through comprehensive ADC services from pre-clinical to commercial from a single source
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White Papers |
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Extractables and Leachables Testing: A Risk Based Approach
RSSL
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events |
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CPhI & P-MEC India
26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India
As
the pharma
industry looks increasingly towards India forhigh quality, low cost pharma solutions, CPhI & P-MEC Indiais the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer.
At
CPhI & P-MEC India, you will meet the movers and shakers from India’s
pharma machinery, technology and ingredients industries, giving you a
competitive advantage that will help grow your business.
More info >> |
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