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.
Challenges And Strategies In Anti-cancer Nanomedicine Development: An Industry Perspective
Abstract Successfully translating anticancer nanomedicines from preclinical proof of concept to demonstration of therapeutic value in the clinic is challenging Having made significant advances with drug delivery technologies we must learn from other areas of oncology drug development where patient stratification and targetdriven design have improv...
Design of experiment based validated stability indicating RP-HPLC method of temozolomide in bulk and pharmaceutical dosage forms
Abstract A simple precise stability indicating RPHPLC method was developed and validated for determination of Temozolomide TMZ in bulk sample and nanostructured lipid carriers A BoxBehnken statistical design with three factors and three levels was employed to optimize the chromatographic conditions The separation was achieved using solvent system...
Ion-pairing HPLC methods to determine EDTA and DTPA in small molecule and biological pharmaceutical formulations
Abstract Ionpairing highperformance liquid chromatographyultraviolet HPLCUV methods were developed to determine two commonly used chelating agents ethylenediaminetetraacetic acid EDTA in Abilify a small molecule drug with aripiprazole as the active pharmaceutical ingredient oral solution and diethylenetriaminepentaacetic acid DTPA in Y
Temperature Excursion Management – A Novel Approach Of Quality System In Pharmaceutical Industry
Abstract Quality of pharmaceutical product largely depends upon by the environment controls during its storage and handling Each pharmaceutical product should be handled and stored under specified storage condition labelled on product information data sheet or product pack Hence the temperature excursions during receipt of raw materials manufactur...
A Simple And Sensitive Method To Analyze Genotoxic Impurity Hydrazine In Pharmaceutical Materials
Abstract Hydrazine NH is a known genotoxic impurity that typically needs to be controlled down to low ppm level in pharmaceutical development Hydrazine however is a challenging molecule to analyze using conventional analytical techniques due to its physical and chemical properties eg lack of chromophore absence of any carbon atom low molecular wei...
New Developments For Antibody-drug Conjugate-based Therapeutic Approaches
Abstract The clinical success of Adcetris brentuximab vedotin and Kadcyla adotrastuzumab emtansine has sparked clinical development of novel ADCs These powerful anticancer agents are designed to allow specific targeting of highly potent cytotoxic agents to tumor cells while sparing healthy tissues Despite the use of tumorspecific antibodies
Near infra red spectroscopy as a multivariate process analytical tool for predicting pharmaceutical co-crystal concentration
Abstract The use of near infra red spectroscopy to predict the concentration of two pharmaceutical cocrystals ibuprofen nicotinamide IBUNIC and carbamazepine nicotinamide CBZNIC has been evaluated A Partial Least Squares PLS regression model was developed for both cocrystal pairs using sets of standard samples to create calib
Assessment of cognitive safety in clinical drug development
Abstract Cognitive impairment is increasingly recognised as an important potential adverse effect of medication However many drug development programmes do not incorporate sensitive cognitive measurements Here we review the rationale for cognitive safety assessment and explain several basic methodological principles for measuring cognition during...
Increasing Patient Involvement In Drug Development
Abstract Background To ensure the creation of treatments that maximize value at the lowest cost all aspects of the health care system need to align with patient needs and preferences Despite growing efforts to engage patients in research and regulatory activities the pharmaceutical industry has yet to max
Regulatory Approval Of Pharmaceuticals Without A Randomised Controlled Study: Analysis Of Ema And Fda Approvals 1999–2014
Abstract Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials RCTs however in some cases regulatory applications lack RCT evidence Objective To investigate the number and type of these approvals over the pa
