Research Insights
Research Insights section focuses on the cutting-edge and breakthrough research that is happening all over the world. Laboratories across the globe are working hard to develop drugs and therapies for various diseases and research insights directly from them add tremendous value.
Evaluation of dose-efficacy of sorafenib and effect of transarterial chemoembolization in hepatocellular carcinoma patients: a retrospective study
Abstract Background Transarterial chemoembolization TACE and sorafenib are the therapeutic standard for intermediate and advanced stage hepatocellular carcinoma HCC patients respectively High costs with adverse events AE of sorafenib might limit sorafenib dosage further affecting therapeutic response To at
Identifying Viable Regulatory and Innovation Pathways for Regenerative Medicine
Abstract The creation of red blood cells for the blood transfusion markets highly represents an innovative approach of regenerative medicine with a medium term year prospect for first clinical study This article describes a research analysis of a project to derive red blood cells from human embryonic stem cells including the systemic challenges a...
Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing
Abstract Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention While it has been used for decades in other industries showing significant advantages the pharmaceutical industry has been slow in its adoption of continuous processing primarily due to regulatory uncertainty This pa...
Utilization of an Eilat Virus-Based Chimera for Serological Detection of Chikungunya Infection
Abstract In December of chikungunya virus CHIKV an alphavirus in the family Togaviridae was introduced to the island of Saint Martin in the Caribbean resulting in the first autochthonous cases reported in the Americas As of January local and imported CHIKV has been reported in American countries with over million suspected cases CHIKV c
FARE-CAFE: a database of functional and regulatory elements of cancer-associated fusion events
Abstract Chromosomal translocation CT is of enormous clinical interest because this disorder is associated with various major solid tumors and leukemia A tumorspecific fusion gene event may occur when a translocation joins two separate genes Currently various CT databases provide information about fusion genes and their genomic elements However no...
Analytical and statistical comparability of generic enoxaparins from the US market with the originator product
Abstract Lowmolecularweight heparins LMWHs are complex anticoagulant drugs made from heparin porcine mucosa starting material Enoxaparin sodium manufactured by Sanofi is one of the most widely prescribed LMWHs and has been used since in the USA In US Food and Drug Administration approval for supplying generic enoxaparin was granted to Sandoz and...
Peptides and Peptidomimetics for Antimicrobial Drug Design
Abstract The purpose of this paper is to introduce and highlight a few classes of traditional antimicrobial peptides with a focus on structureactivity relationship studies After first dissecting the important physiochemical properties that influence the antimicrobial and toxic properties of antimicrobial peptides the contributions of individual am...
Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Metformin, or Psychotropic Drugs
Abstract Background In an Indian parliamentary committee reported that manufacturing licenses for large numbers of fixed dose combination FDC drugs had been issued by state authorities without prior approval of the Central Drugs Standard Control Organization CDSCO in violation of rules and considered tha
Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Abstract Very recently Food and Drug Administration FDA has approved a few new drug applications NDA with regulatory flexibility for quality by design QbD based analytical approach The concept of QbD applied to analytical method development is known now as AQbD analytical quality by design It allows the analytical method for movement within method...
An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile
Abstract We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between primary active ingredient and secondary patents patents on modified compounds formulations dosages particular medical uses etc There is prior evidence that secondary patents are used by pharmaceutical originator c
