The purpose of this implantation study was to evaluate possible toxic effects and quality and quantity of resorption of two different resorbable gelatine sponges when implanted into the paravertebral muscle of the rabbit for a period of 7, 14 or 21 days and to evaluate bioequivalence of two types of test material. Test materials (Gelaspon) and a commercially available reference material were compared in three groups with 6 rabbits each. Tissue reaction to the implants and sponge degradation were scored on a graded scale and the sponges were compared for evaluation. No treatment-related mortality or body weight changes were observed. Clinical signs, indicative of local effects, were mainly seen for reference material. Tissue reaction after 7 days was comparable, after 14 and 21 days a significant increase in granulomatous reaction was seen for reference material. Sponge degradation was complete for test materials after 14 and 21 days without inflammatory tissue reaction, but small sponge rests of reference material were still present, accompanied by an increased inflammatory response. Results show test materials to fulfil the clinical requirements for implant material concerning fast resorption without inflammatory reactions and its superiority to reference material. Bioequivalence of used types of test material could be confirmed.
Download full-text PDF |
Source |
|---|
Publication Analysis
Top Keywords
Similar Publications
Hemispheric asymmetries in episodic memory.
Handb Clin Neurol
March 2025
Laboratory of Neuropsychology of Memory, IRCSS Santa Lucia Foundation, Rome, Italy; Department of Systems Medicine, Tor Vergata University, Rome, Italy. Electronic address:
The term "episodic memory" refers to our ability to remember past personal experiences. This ability is severely disrupted following bilateral damage to a dedicated neural substrate located symmetrically in the mesial temporal lobes. Milder deficits are also observed following unilateral damage to the same structures.
View Article and Find Full Text PDFHydrodynamics of the small vessel as described in the Chinese Pharmacopoeia.
Int J Pharm
March 2025
New Jersey Institute of Technology, Otto H. York Department of Chemical and Materials EngineeringNewark, NJ 07102-1982, USA. Electronic address:
Small volume dissolution systems are commonly used in dissolution testing, primarily in method development for low dose formulations compared to standard dissolution apparatuses used with evaluation of larger formulations. This is typically done because of cost savings associated with using smaller media volumes and sample sizes, to overcome the lack of material in early development, and to provide higher analytical sensitivity and discrimination ability. The Chinese Pharmacopoeia (CP) includes a small dissolution apparatus in their list ("Method 3 (Small Vessel)") (The State Pharmacopoeia Commission of P.
View Article and Find Full Text PDFRegulatory Frameworks and Filing Discrepancies in Generic Drug Approvals: A Cross-Regional Study with Analysis of FDA ANDA Deficiencies.
Ann Pharm Fr
March 2025
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management SVKM's NMIMS, V. L. Mehta Road, Vile Parle (W), Mumbai, 400056, India. Electronic address:
Objectives: This research aims to analyse the regulatory frameworks for generic drug applications in the US, EU, India, Japan, and China comparing their filing requirements to identify gaps and areas for harmonization. Additionally, it focuses on examining common deficiencies in ANDA from FDA submissions in 2014-2023 to address issues, facilitating more efficient approvals and minimizing delays.
Material And Methods: The research involved analysing regulatory documents available on official websites, including the FDA, EMA, CDSCO, PMDA, and NMPA to achieve first objective.
Internalization and Colocalization of a Polyclonal Antibody Against Porphyromonas gingivalis FimA type I in Infected Cells.
Eur J Dent
March 2025
Department of Oral Biology, Faculty of Dentistry, Naresuan University, Phitsanulok, Thailand.
Objective: The aim of this work was to investigate the effect of a rabbit polyclonal antibody specific to FimA type I (FimI) protein internalized into infected cells.
Materials And Methods: Rabbits were immunized with FimI protein and the serum was collected for immunoglobulin (Ig) purification. For visualization of the antibody inside the cells, it was labeled with Cy3 dye.
Accurate and precise Th/Th isotope ratio measurement by multi-collector inductively coupled plasma mass spectrometry using a pre-cell mass filter for collision/reaction cell (MC-ICP-MS/MS).
Talanta
March 2025
European Commission, Joint Research Centre (JRC), Karlsruhe, Germany.
In this paper we present the high-precision and accurate Th/Th isotope ratio measurement by a novel multi-collector inductively coupled plasma mass spectrometer with a pre-cell mass filter and a MS/MS collision/reaction cell (Neoma™ MC-ICP-MS/MS). No tailing correction is needed for the Th signal, as the tailing of an adjacent high intensity peak (abundance sensitivity) is effectively reduced due to high extent of Ar-based ion removal before the electrostatic analyser/magnetic sector. The obtained abundance sensitivity at m-2 (i.
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!