Clinical Trials of Suspension Drug Products

2009 ◽  
pp. 231-243
Author(s):  
G. Michael Wall ◽  
Terry K. Wiernas
Keyword(s):  
Clinical Trials ◽  
Drug Products

scholarly journals Expanded mesenchymal stem cell transplantation is safe in both local injection and vein transfusion

2017 ◽  
Vol 4 (3-4) ◽  
pp. 234-235 ◽  
Author(s):  
Vlassov V Salval ◽  
Yone Moto
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Stem Cell ◽  
Clinical Applications ◽  
Local Injection ◽  
Mesenchymal Stem Cell Transplantation ◽  
Routine Treatment ◽  
Drug Products ◽  
The World

More than 500 clinical trials are using mesenchymal stem cells (MSCs) in the world to treat some different diseases. The safety of expanded MSC transplantation is the most important thing to ensure that this therapy can become the routine treatment for human diseases. More than five MSCs based stem cell drug products are approved at various countries demonstrated that expanded MSCs are safe in both local injection and transfusion. Moreover, some recent reports for 5 and 10 years followed-up clinical trials using expanded MSCs confirmed that there is not different tumorigenesis between the patients with and without expanded MSC transplantation. This letter aims to provide some evidences about the safety of expanded MSCs in clinical applications. However, the MSC quality should be stritcly controlled during the in vitro MSC expansion.

On Innovative Activity in Pharmaceutical Industry

Vestnik NSUEM ◽  
2021 ◽  
pp. 168-174
Author(s):  
M. I. Berkovich ◽  
A. Yu. Volin
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clustering Algorithm ◽  
Innovative Activity ◽  
Innovation Activity ◽  
Drug Products ◽  
Pharmaceutical Manufacturers

The article provides with different approaches to the assessment of pharmaceutical manufacturers’ innovation activity. The peculiarities of pharmaceutical industry product that can be characterized as innovative are taken into consideration. Special attention has been given to the pharmaceutical industry peculiarities originating from differentiation of original drug products and generics in the structure of pharmaceutical industry production. Based on these findings the classification of Russian pharmaceutical manufacturers in accordance with their innovation activity extent evaluated by their activity in clinical trials conducting was developed. The classification is based upon k-means clustering algorithm with 5 clusters specified.The small amount of manufacturers involved in clinical trials conducting and some optimistic insights about the original products share were concluded hereafter.

Design and Analysis of Clinical Trials for Anti-Infective Drug Products

1990 ◽  
Vol 24 (1) ◽  
pp. 213-224 ◽  
Author(s):  
Ralph D. Harkins ◽  
Renata Albrecht
Keyword(s):  
Clinical Trials ◽  
Drug Products

scholarly journals Development of multipurpose technologies products for pregnancy and STI prevention: update on polyphenylene carboxymethylene MPT gel development†

2020 ◽  
Vol 103 (2) ◽  
pp. 299-309
Author(s):  
Mary Weitzel ◽  
Barbara Best North ◽  
Donald Waller
Keyword(s):  
Clinical Trials ◽  
Transmitted Disease ◽  
Sti Prevention ◽  
Sexually Transmitted ◽  
Drug Products ◽  
Control Drug ◽  
Medical Issues ◽  
Complex Development ◽  
Contraceptive Activity ◽  
Early Human

Abstract Current modern contraceptives rely heavily on the use of hormones. These birth control drug products, including pills, patches, injections, and IUDS, have been extremely beneficial to millions of women and their families over the past 50 years. But a surprisingly high number of women abandon such modern methods, many because they cannot tolerate the side effects and others because they have medical issues for which hormonal methods are contraindicated. In addition, modern hormonal methods are simply not available to many women. The extent of this problem is steadily becoming more apparent. We present the case for developing simple nonhormonal vaginal products that women can use when needed, ideal products that are multipurpose and offer both contraception and sexually transmitted disease protection. Gel-based vaginal products are particularly well suited for this purpose. Gels are easy to use, highly acceptable to many women, and can be safely formulated to enhance natural vaginal defenses against infection. However, the development of a new chemical entity for this application faces significant technical and regulatory hurdles. These challenges and our solutions are described for polyphenylene carboxymethylene (PPCM), a novel topical drug in a vaginal gel nearing human clinical trials. We have advanced PPCM from benchtop to IND-enabling studies and provide a brief description of the complex development process. We also describe a simple lab assay which can be used as a biomarker for contraceptive activity to enable pharmacodynamic studies in vaginal contraceptive development, both preclinically and in early human clinical trials.

scholarly journals Pharmacovigilance Safety Monitoring in Clinical Trials

2021 ◽  
Vol 70 (1) ◽  
Author(s):  
Supriya Nikam ◽  
Anjali Jambhulkar ◽  
Kalyani Kayande ◽  
Abhilasha Ghule ◽  
Akash Inde
Keyword(s):  
Clinical Trials ◽  
Patient Safety ◽  
Drug Development ◽  
Drug Safety ◽  
Safety Monitoring ◽  
Pharmacovigilance System ◽  
Major Purpose ◽  
Drug Products ◽  
Adverse Event Data ◽  
Post Marketing

Pharmacovigilance is that the science and activities associated with the gathering, detection and assessment of adverse event data. Major purpose of pharmacovigilance is to gauge the benefit- risk profile of drug for better efficacy and safety to be used in patients. Pharmacovigilance plays a major role in rationale use of drug which provides the information about the adverse drug reactions which seen in patients. In terms of volume Indian Pharma industry is third largest in world and in terms of value id thirteen largest in world. India is also known as a hub for clinical research and drug development. There is a requirement of a global and standardized pharmacovigilance system in India for better safety assessment in India. In drug development process the only priority of clinical trials is to make sure patient safety during and after the trials. A critical component throughout the drug development life-cycle is monitoring patient safety. Patient must be treated consistent with the requirements and illness of patient therefore the utmost value is given to monitoring of patient safety in the least levels of drug development. Such monitoring may be a dynamic process so to approach safety monitoring. To ensure a systematic approach to safety monitoring pharmaceutical sponsor must work proactively and collaboratively with all stakeholders. We have to focus upon all the aspects of drug safety in clinical trials including basics of drug safety, regulatory aspects of drug safety, patient suitability for safety in trials, post marketing safety and causality risk assessment of the drug products.

Localization of Gallium-67 in Peritoneal Cells by Electron Microscopic Autoradiography

1973 ◽  
Vol 31 ◽  
pp. 404-405
Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Tumor Tissue ◽  
Soft Tissue Tumors ◽  
Clinical Usefulness ◽  
Electron Microscopic ◽  
Normal Cells ◽  
Electron Microscopic Autoradiography ◽  
Peritoneal Cells ◽  
Gallium 67

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.

Patients' satisfaction in clinical trials

2000 ◽  
Vol 248 (6) ◽  
pp. 441-442 ◽  
Author(s):  
L. Terenius
Keyword(s):  
Clinical Trials ◽  
Patients Satisfaction
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