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References in periodicals archive ?
Before the initiation of clinical studies using an IMP, the MHRA first requires submission and acceptance of an Investigational Medicinal Product Dossier (IMPD).
If the investigational medicinal product (IMP) is a protein or considered a high-risk compound, it is preferable to administer the dose intravenously which allows the clinic to stop the infusion if the subject should experience adverse reactions.
- Stempeutics received DCGI clearance for the company's Investigational Medicinal Product - "Stempeucel" for Phase II clinical trials for four debilitating diseases- It is a multicentric, placebo controlled, double blind, allogeneic clinical trials addressing Osteo Arthritis, Liver Cirrhosis, Diabetes Mellitus type 2 and Chronic Obstructive Pulmonary Disease- Stempeutics established large scale production of Mesenchymal Stem Cells for Clinical Trials using a patented upscaling process- Based on the successful outcome of clinical studies plans to introduce the FIRST stem cell based drug - available off the shelf in India by end of 2013.
The consequence of this is that firstly stem cell-based therapies will be subject to the clinical trials regime under the 2001 clinical trial directive, which require that a clinical trial is authorised by the competent authority in each member state (in this case obtaining 'positive' rather than 'negative' approval) and has been subject to ethical review and that it is conducted in accordance with GCP using investigational medicinal product manufactured in accordance with GMP.
Aastrom says initiation of the trial followed the Diabetes Center's receipt of the licenses and the Investigational Medicinal Product Dossier (IMPD) necessary to manufacture and use cells for clinical trials in compliance with the new European Union directives.
RP-L102 is currently being studied in a Phase 1/2 clinical trial in the European Union with an Investigational Medicinal Product Dossier in place with the Spanish Agency for Medicines and Health Products.
The Company had previously announced the submission of an Investigational Medicinal Product Dossier for its lead product MS1819-SD, a recombinant lipase for the treatment of exocrine pancreatic insufficiency caused by chronic pancreatitis and cystic fibrosis on October 20th, 2017.
In addition, study preparations such as production of investigational medicinal product, approval of the clinical trial application, IND approval, ethics committee approval, amongst others, need to be completed before study start.
Diapharm produces IMPD (Investigational Medicinal Product Dossiers) according to EU specifications; for example, it coordinates clinical studies and takes care of laboratory analysis and batch release for imports of genetically engineered drugs, among others.
It lists the documentation to be submitted in support - on the quality and manufacture of the investigational medicinal product, any toxicological and pharmacological tests, the protocol and clinical information on the investigational medicinal product including the investigator's brochure.
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