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Formulation, Development & Delivery In-Depth Focus 2018
In this supplement: Real-time PCR detection of Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures, and an ICH Q3C(R5) elemental impurities update.
Issue 6, 2018
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
Blood tests could lead to personalised cystic fibrosis treatment
A blood test could transform the way doctors treat people affected by cystic fibrosis, helping to personalise treatments to individual people...
Application Note: Verification of three different Opadry whites using a handheld Raman analyser
Pharmaceutical companies that manufacture tablets, capsules, and other solid dosage forms use film coatings on their products to differentiate appearance and to improve palatability by masking unpleasant tastes or odors.
Application Note: Transforming your bioanalysis operations
Many bioanalytical labs work with a crowded and siloed set of systems and processes. From part electronic to part paper-based workflows, to standalone point-solutions, the result is a lack of insight into data and slower reporting and results handling.
Application Note: Real time, low flow, pharmaceutical soil cleanability profiling with TOC and conductivity
Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
Application Note: Tracking fate and purge of impurities and calculating carryover
The purpose of process development in pharma is to select and optimise a synthetic route to produce the active pharmaceutical ingredient (API) by the safest, cheapest, fastest, and cleanest (by green chemistry where possible) route, following both Good Laboratory Practice (GLP) and Quality by Design (QbD) principles.
Sprayable gel with CD47 blockers could be the future of drug delivery for cancer
A sprayable gel containing calcium carbonate nanoparticles with antibodies targeted to block CD47, could be the future of drug delivery for cancer...
Scientific Poster: How complementary chromatographic methods can support a full analytical picture in pharmaceutical drug development
HPLC is a rapid, accurate and sensitive method for determination of pharmaceutical drugs, degradations and impurity profiling. It is a preferred method for analytical characterisation during drug development.
‘Record year for pharma packaging and drug delivery innovation’ says Pharmapack
In an all-time record year for FDA approvals (48 so far in 2018), Pharmapack Europe reports that innovation is also accelerating across the drug delivery and packaging industries...
Phase III KATHERINE trial crossed early reporting boundary and met its primary endpoint
A phase III clinical trial showed that neoadjuvant chemotherapy and trastuzumab reduced the risk of recurrence of HER2-positive early-stage breast cancer...
Trastuzumab taken with carvedilol leads to less heart damage
A team of Iranian researchers have determined that trastuzumab taken with a heart drug leads to less heart damage in breast cancer patients...
Rivaroxaban reduced blood clots and related death in cancer patients
Through a clinical trial, Cleveland researchers have identified how rivaroxaban reduces blood clots in cancer patients and also decreases related deaths...
Discovery to save more women in childbirth from postpartum hemorrhaging
The development of a drug that could be used to save women from postpartum hemorrhaging, could save many thousands of women each year...