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.

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

Defining the In Vivo Phenotype of Artemisinin-Resistant Falciparum Malaria: A Modelling Approach

Abstract Background Artemisininresistant falciparum malaria has emerged in Southeast Asia posing a major threat to malaria control It is characterised by delayed asexualstage parasite clearance which is the reference comparator for the molecular marker Kelch and in vitro sensitivity tests How

Integrity testing of Planova™ BioEX virus removal filters used in the manufacture of biological products

Abstract Confirmation of virus filter integrity is crucial for ensuring the safety of biological products Two main types of virus filter defects may produce inconsistent and undesirable performance in virus removal improper poresize distribution across the membrane and specific damage such as tears broken fibers or pinholes Two integrity tests are...

Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation

Abstract Background In many European countries medicines promotion is governed by voluntary codes of practice administered by the pharmaceutical industry under its own system of selfregulation Involvement of industry organizations in policing promotion has been proposed to deter illicit conduct but few detailed studies on selfregulation have been...

Synthetic Biodegradable Polymers Used in Controlled Drug Delivery System: An Overview

Abstract Polymers are becoming increasingly important in the field of drug delivery The pharmaceutical applications of polymers range from their use as binders in tablets to viscosity and flow controlling agents in liquids suspensions and emulsions Use of polymer is now extended to controlled release and targeting drug delivery system Polymers are...