Drug Regulators, EMA (EMEA), Re-Publish Note for Guidance on the Investigation of Bioavailability and Bioequivalence
Filed in clinical, March 31, 2010, 9:48 amTo exert an optimal therapeutic action an active moiety should be delivered to its site of action in an effective concentration for the desired period. To allow reliable prediction of the therapeutic effect the performance of the dosage form containing the active substance should be well characterised.
Drug Regulators, EMEA (EMA), Publish Draft Community List Entry on Vitis Vinifera Var. Tunctoria L., Folium
Filed in Herbal, March 30, 2010, 9:43 amENTRY TO LIST OF HERBAL SUBSTANCES, PREPARATIONS AND COMBINATIONS THEREOF FOR USE IN TRADITIONAL HERBAL MEDICINAL PRODUCTS
Drug Regulators, EMA (EMEA), Publish Comments received on draft appendix 2 to the Guideline on the Evaluation of Anticancer Medicinal Products in Man
Filed in clinical, March 29, 2010, 9:43 amInterested party (Organisations or individuals) that commented on the draft Guideline as released for consultation
1 EFPIA
2 Mundipharma Research Ltd
3 MSD
4 PSI
5 Roche
6 EORTC
Twitter Weekly Updates for 2010-03-28
Filed in Uncategorized, March 28, 2010, 2:20 pmConsultancy outcomes should be consistent with the terms of insurance! Ask to see insurance certs when buying services! # Regulatory advice, sometimes its a few short questions, but it can be a huge answer! # Lots of new training opportunities will be comming out in next few months! Keep those eyes peeled to our newsletter! [...]
Drug Regulator, FDA, Publishes Guidance on Pharmacokinetics in Patients with Impaired Renal Function, Study Design, Data Analysis, and Impact on Dosing and Labeling.
Filed in clinical, March 22, 2010, 10:49 amThis guidance is intended to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. It provides recommendations on when studies should be conducted to assess the influence of renal impairment on the pharmacokinetics of an investigational drug, the design of such studies, and how such studies should be carried out.
Twitter Weekly Updates for 2010-03-21
Filed in Uncategorized, March 21, 2010, 2:20 pmBusiness planning for healthcare technologies is all about telling a story! # Powered by Twitter Tools
Drug Regulators, EMA (EMEA), Publish Draft Guidance on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
Filed in biotechnology,manufacturing, March 17, 2010, 2:49 pmThis guideline outlines the requirements for the data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing biological / biotechnology derived substances.
Drug Regulators, FDA, Publish Guidance S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Filed in pre-clinical, March 16, 2010, 2:30 pmThe 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, EMEA (EMA), Publish Draft Guidance on the Validation of Bioanalytical Methods
Filed in Diagnostic,clinical, , 11:27 amThis guideline defines key elements and provides recommendations for the validation of bioanalytical methods. The guideline focuses on the validation of the analytical methods used for pharmacokinetic sample analysis. In addition, guidance will be provided with regard to the actual analysis of study samples.
Testimonial
Filed in Uncategorized, March 15, 2010, 2:25 pmI had a very good time to work with Damien during the Yorkshire Enterprise Fellowship training scheme. Based on knowledge and experience of both bioscience and business, Damien gave me a huge amount of inspiration and the ability to explore the world of business of bioscience translation. Damien’s input was very valuable in helping establish what the commercial opportunity was, and how my product would fit into the market and what was needed in order to get in there. – Alexin Cheng – The University of York
METRC – Short Term Project Funding Call
Filed in Fund raising, , 2:15 pmShort Term Project Funding is designed to support small research projects to explore the feasibility of innovative new products and processes. In the first stage, funds of up to £3,000 are available to support collaborative projects between industry and METRC’s academic members.Second stage funds of £7,000 are available for the most successful projects providing there is a match from the industrial partner.
Twitter Weekly Updates for 2010-03-14
Filed in Uncategorized, March 14, 2010, 2:20 pmWhen you have to guess, and educated guess carries much more weight than an uneducated one! # Don't underestimate the beauty of electronic document submission! Just printed and posted an FDA orphan application, heavy!!! # I just updated my Squidoo page: First In Man Clinical Trials Regulations course http://tinyurl.com/yfp8l5o # Regulation of first in man [...]
Drug Regulators, FDA, Publish Guidance on the Use of Bayesian Statistics in Medical Device Clinical Trails.
Filed in clinical,devices, , 9:44 amThis document provides guidance on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods. The purpose of this guidance is to discuss important statistical issues in Bayesian clinical trials for medical devices
Drug Regulators, MHRA, Start Public Consultation To Extend Maximum Treatment Period and Pack Size Changes to Voltarol Emugel
Filed in manufacturing,marketing, March 13, 2010, 9:38 amConsultation document ARM 66 which includes the applicant’s Reclassification Summary and Patient Information Leaflet, has been posted
on the MHRA website today (www.mhra.gov.uk).
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, EMA (EMEA), Publish Concept Paper on Need for Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
Filed in manufacturing, , 9:26 amThe Joint Human/Veterinary “Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation” (CPMP/QWP/576/96 Rev 1; EMEA/CVMP/373/04) came into effect on 1 December 2005. Since then, changes have been made to the underlying variations legislation. The guideline therefore needs to be revised to be in line with these changes.
Drug Regulators, EMA (EMEA), Publishes Draft Guidance on Real Time Release Testing (Parametric Release)
Filed in manufacturing, March 11, 2010, 9:22 amMedicinal products must comply with the approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the finished product, according to the approved specifications.
Drug Regulators, EME (EMEA), Publish Concept Paper on Revision of the Guideline on Process Validation
Filed in manufacturing, , 9:15 amThis concept paper addresses the need to update the guideline on Process Validation. This guideline was originally adopted in February 2001. With the development of new ICH guidelines Q82, Q93 and Q104, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.
Drug Regulators, EMA (EMEA), Publish Consultation on Its Road Map to 2015
Filed in regulatory, March 10, 2010, 9:08 amThe European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary on 26 January 2010
European and international partners, stakeholders, including patients’ and doctors’ organisations as well as pharmaceutical industry, and the public are invited to make their views known on the Agency’s future strategic vision, set out in the document ‘The European Medicines Agency Road Map to 2015
Drug Regulators, FDA, Publish Guidance on Characterisation and Qualification of Cell Substances and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Diseases
Filed in biotechnology,manufacturing, March 9, 2010, 9:02 amThe, FDA, are providing manufacturers of viral vaccines, with guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use
