白皮书
Our white papers and technical bulletins are written by industry experts from many different fields, exploring and commentating on a range of complex subjects.
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Nitrosamines: Questioning the Current Analytical Approach
In recent years, multiple drug products (DPs) have been recalled following the discovery of nitrosamine impurities. We look at current investigative methods and the potential for a more effective analytical approach. |
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Cell Substrate Characterization In Vitro-based Virus Detection Methods
This white paper explores how all components of commercial biopharmaceuticals and vaccines must undergo extensive safety testing to demonstrate identity, stability and purity. |
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PowerS(h)elling SAS
A look at how Microsoft® PowerShell™ can be utilized to facilitate batch processing in SAS® and the benefits of creating a GUI, also using PowerShell, to configure and control SAS processes. |
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Pharmacokinetic and Statistical Considerations in First-in-human Clinical Trials – Case Study
Given the exploratory nature of First-in-Human (FIH) studies, 这个问题, “什么, 如果有任何, statistical analysis is required for pharmacokinetics (PK) data?" has been asked before. This article investigates that question. |
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Hard Brexit Is a Reality: 4 Things Your Business Has to Do Right Now |
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Decoding FSMA 认证 – A Practical Guide
This document provides a practical guide to understanding FSMA certification. |
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Benefits of Integrating Full Characterization to Early Method Development - Focus on SEC-MALS
COVID-19 has highlighted the need for faster methodologies when developing new drug products. We look at how integrating the SEC-MALS method at an earlier stage in the development process will accelerate speed-to-clinic without compromising patient safety. |
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Advancing the Detection of E&L by Pharma Manufacturers
In this document, we look at how coupling the headspace sampling technique with an HRAM GC-MS system delivers a powerful technique to quickly assess and quantify potentially dangerous, untargeted volatile extractables in pharma workflows. |
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Managing Human Challenge Trials: A Case Study
Volunteer Infection Studies (VIS) or Controlled Human Infection Models (CHIM) are an extremely effective way to gather early clinical evidence on efficacy, minimize potential risks, and maximize the outcomes when progressing a new drug or vaccine onto critical clinical studies. Their success relies on careful preparation by an experienced team that is capable of adequately managing the risks associated with the study. |
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Nitrosamine Testing: The Regulatory Aspects
In this technical bulletin we explain the regulatory aspects for nitrosamine impurities testing and provide more details on a risk assessment process. |