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Management of Investigational Medicinal Product in the Clinical Trial, the Product Specification File and the Trial Master File
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Pharmacuetical Analysis lecture notes
Pharmaceutical analysis involves the separation, identification, quantification and purity testing of substances in pharmaceutical samples. It is used to ensure safety, efficacy and stability of drugs. Some key techniques used in pharmaceutical analysis include separation and purification methods, identification tests, quantitative assays and limit tests to detect impurities. Proper pharmaceutical analysis is important for quality control and compliance with regulatory standards during drug development, manufacturing and release.
Phụ lục 13 GMP EU. Điều tra thuốc hóa dược
Phụ lục 13 GMP EU về Điều tra thuốc hóa dược. Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU
Use of Chemical Characterization to Assess the Equivalency of Medical Devices...
Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials describes chemical characterization techniques and why they are important.
Gene Therapy
Gene therapy involves introducing genetic material into human cells to treat diseases. It aims to cure diseases by adding extra genes or replacing faulty genes. There are still many challenges to gene therapy, including developing safe and effective viral and non-viral vectors to deliver genes, avoiding unintended effects, and establishing regulations for clinical trials and production. As the field continues to advance, dedicated facilities and standardized procedures will be important to ensure patient safety.
Schedule Y
The document outlines appendices related to data requirements for conducting clinical trials of new drugs in India. Appendix I provides details on various types of data that must be submitted, including chemical/pharmaceutical information, animal pharmacology/toxicology studies, human clinical trial phases, regulatory information from other countries, and prescribing information. It also describes stability testing and validation requirements. Appendix II discusses the structure and contents of clinical study reports. Appendix III covers principles of animal toxicology studies.
Immunological products quality control
This document outlines definitions, tests, specifications, and procedures for vaccines, immunoglobulins, diagnostic antigens, and their packaging and stability studies. It defines vaccines, immunoglobulins, and diagnostic antigens. It describes physico-chemical, biological activity, analytical, and other tests done during development and production. It lists specifications that must be provided for the final product and additional specifications for oral liquids and parenterals. It also covers batch manufacturing records, packaging material specifications, and stability studies on the finished product.
fda guidles.pptx
The FDA regulates food, drugs, medical devices and other products. It oversees the drug approval process which involves preclinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy and side effects. If approved, the drug can be marketed and is monitored for side effects. The document outlines the drug approval process and regulations around generic drugs, biologics, manufacturing and product changes.
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Thesis Defense Presentation
- 1. Management of investigational medicinal product Candidate Francesco Guarino Ancona, ITALY 12 February 2016 Product Specification file and the Trial Master file in the Clinical Trial, the
- 2. Essai Clinique à Rennes: Décès du patient en ètat de mort cérébrale
- 5. medicinal product { }D.L. 219/2006 Dir 2001/83/EC substance/ combination of substances action pharmacological immunological metabolic
- 6. { } pharmaceutical form of an active substance or placebo investigational medicinal product being tested D.L. 211/2003 Dir 2001/20/EC IMP in Clinical Trial
- 7. medicinal product used but not object of the study { }D.L. 200/2007 Dir 2005/28/EC
- 8. NIMPNon Investigational Medicinal Product D.M. 21/12/2007{ }
- 9. IMP Cycle
- 10. Good Manufacturing Practice { Eudralex vol.4 Annex 13 } Production
- 17. Management of investgational medical product safety or quality?
- 18. Thanks
Editor's Notes
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- Vorrei Affrontare il DISCORSO saltando l’analisi del lessico ma DEFINIZIONE GIURIDICA
- CORREGGERE RIPRISTINARE MODIFICARE f( fisiologiche)
- il legislatore EQUIPARA la f( IMP al Placebo
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- RINFRESCATA NOZIONE possiamo analizzare CICLO le norme di buona Pratica Clinica Attribuiscono RESPONSABILITà SPERIMENTATORE .... MONITOR .... SPONSOR AGGIORNARE DOSSIER JENSSEN ANSIOLITICO fase II
- GARANTIRE STANDARD ELEVATI formazione Staff Gestione Qualità QA prob MIX-UP CROSS-CONTAMINATION processi PRODUTTIVI VALIDATI domanda BREVETTO BIAL dovuto aggiungere fase PURIFICAZIONE SOP ritiro richiamo distruzione QP documentazione psf
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- responsabilità SPERIMENTATORE
- RISCONTRATE DAI MONITOR E AUTORITà con inadeguata SICUREZZA conf cieco DATI etichette fuori legge somm. non documentata Dati non attendibili Tracc SICUREZZA
- dopo tragedia doveroso SPECULAZIONI-CONGETTURE SCIENCE TRANSLATION MEDICINE LEGAME IRREVERSIBILE MERCK PERICOLO LEGAME IRREVERSIBILE JENSSEN 68 RECETTORI SICUREZZA ATTENDIBILITà DATI RICHIESTI GCP PASSANO PER UN ELEVATO STANDARD QUALITATIVO QUINDI DI COSA PARLIAMO