Tag Archive
The following is a list of all entries tagged with pre-clinical:
Drug Regulators, FDA, Publishes Guidance on S9 Non-Clinical Evaluation for Anticancer Pharmaceuticals
Filed in pre-clinical, March 12, 2010, 9:31 amThe purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. The guidance provides recommendations for nonclinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options.
Drug Regulators, EMEA, Publish ICH S6(R1), Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Filed in biotechnology,pre-clinical, December 27, 2009, 10:28 amThis guidance is intended primarily to recommend a basic framework for the preclinical safety evaluation of biotechnology-derived pharmaceuticals. It applies to products derived from characterised cells through the use of a variety of expression systems including bacteria, yeast, insect, plant, and mammalian cells
Drug Regulators, EMEA, Publish ICH S9 Guidance, Nonclinical Evaluation for Anticancer Pharmaceuticals
Filed in pre-clinical, December 26, 2009, 10:23 amThe purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals.
Drug Regulators Publish ICH consideration on Virus and Vector Shredding
Filed in biotechnology,clinical,pre-clinical,regulatory, August 21, 2009, 8:02 amFor the purpose of this ICH Considerations document, shedding is defined as the issemination of the virus / vector through secretions and/or excreta of the patient.
Cardiovascular Toxicity (QT prolongation) in Drug Development Overview
Filed in clinical,pre-clinical,regulatory, March 31, 2009, 5:48 pmQT prolongation, however some people are finding they need a little more information if they are going to tackle and plan for it within their drug development programmes.
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