|
New Publications
our latest releases... SPRING 2008 Two new Supplements to Clinical Research Manual
CRM24 Simulation of clinical trials by Professor Tony Greenfield A fascinating review of how modern computer technology can create a virtual clinical trial. Running simulation before starting a real clinical trial will help you to take better decisions and prevent you from taking wrong decisions - Simulation will save you money! CRM25 MedDRA: Medical Dictionary for Regulatory Activities by Dr Christina Winter MedDRA is a dictionary of medical terms used in the pharmaceutical regulatory environment. This newly published Supplement updates an earlier by Elliot Brown and provides the latest information on how to use MedDRA.
Two new Supplements to Industrial Pharmaceutical Microbiology standards & controlsIPM07 Filtration by Claire Jarmey-Swan Information on the design, construction and media used in the microfiltration of heat-sensitive fluids and gases to provide sterile products for the pharmaceutical industry. IPM08 Regulatory expectations for non sterile manufacture of pharmaceutical dose forms by Stewart Green Guidance for the manufacture and control of non sterile dose forms (tablets, liquids, creams, ointments, aerosols, suppositories and transdermal patches) and comment on the relative risks and preventative measures expected by the regulators.
|
