The encapsulation of tissue in semi-permeable membranes is a technology with high potential and in due time several new therapies based on this technology will be tested in clinical trials. Recent, new legislation requires that these investigational medicinal products used in clinical trials Phase I must be produced according to Good Manufacturing Practice (GMP). Consequently, the activities of GMP are expanding to the field of research and researchers might need to change developed protocols in order to meet GMP legislation. This chapters gives an overview of the overall guidelines covering GMP and more specific guidelines dealing with cell based therapies and gene therapy.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1007/978-1-4419-5786-3_4 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Intranasal administration of antiseizure drugs using new formulation trends: one step closer to reach clinical trials.
Expert Opin Drug Deliv
January 2025
CICS-UBI - Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal.
Introduction: Although there are numerous options for epilepsy treatment, its effective control continues unsatisfactory. Thus, search for alternative therapeutic options to improve the efficacy/safety binomial of drugs becomes very attractive to investigate. In this context, intranasal administration of antiseizure drugs formulated on state-of-the-art nanosystems can be a promising strategy.
View Article and Find Full Text PDFAdverse Events of Factor Xa Inhibitors in Pediatric Patients: A Meta-analysis and Pharmacovigilance Study.
Paediatr Drugs
January 2025
Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China.
Background: This study aimed to provide a comprehensive review of adverse events (AEs) associated with factor Xa (FXa) inhibitors in pediatric patients.
Methods: We searched PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the European Union Clinical Trials Register for English-language records from the establishment of the database up to October 17, 2023.
Relationship Between Laryngopharyngeal Reflux, Gastroesophageal Reflux Disease, and Dental Erosion in Adult Populations: A Systematic Review.
Dig Dis Sci
January 2025
Department of Otorhinolaryngology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Objectives: As one of the most common complications of laryngopharyngeal reflux or gastroesophageal reflux disease, dental erosion presents a significant association with laryngopharyngeal reflux. This study aimed to elucidate the role of laryngopharyngeal reflux and gastroesophageal reflux disease on the severity and occurrence of dental erosion in adult populations.
Methods: A comprehensive search was performed in the databases of PubMed/MEDLINE, Web of Science, Cochrane Library, and Scopus for English literature published from July 1999 to June 2024.
Unraveling Cardiovascular Risks and Benefits of COVID-19 Vaccines: A Systematic Review.
Cardiovasc Toxicol
January 2025
RAK College of Medical Sciences, RAK Medical and Health Sciences University, Ras Al Khaimah, United Arab Emirates.
The rapid development and deployment of mRNA and non-mRNA COVID-19 vaccines have played a pivotal role in mitigating the global pandemic. Despite their success in reducing severe disease outcomes, emerging concerns about cardiovascular complications have raised questions regarding their safety. This systematic review critically evaluates the evidence on the cardiovascular effects of COVID-19 vaccines, assessing both their protective and adverse impacts, while considering the challenges posed by the limited availability of randomized controlled trial (RCT) data on these rare adverse events.
View Article and Find Full Text PDFThe effect of different timings of protein supplementation on variable outcomes in hemodialysis patients: a randomized clinical trial.
Clin Exp Nephrol
January 2025
Internal Medicine Department, El Qabbary General Hospital, Ministry of Health, Alexandria, Egypt.
Background: Oral nutritional supplements (ONS) are commonly prescribed to provide protein and energy to hemodialysis (HD) patients. There is a debate about the appropriate timing to administer ONS. We aimed to study the effect of different timings of ONS on variable outcomes in HD patients.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!