News & Analysis on Clinical Trial Services & Contract Research And Development
The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical methods.
Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders should actively partake in their evolution and prepare for the ensuing changes.
Understanding pharmacokinetic behaviors ahead of later-stage development means making informed decisions earlier. This enhanced capability helps your drug development projects meet tight timelines and budget objectives.
Invivo: Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach. However, an enteric formulation is often accompanied with a higher development effort in the first...
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can be fraught with risk.
As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams have decades of experience formulating, testing, and manufacturing pharmaceutical products that...
89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry survey. This rapid technological development will make clinical trials more accessible to...
Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory knowledge and scientific expertise in this therapeutic area. Partnering with a single integrated...
Patient co-creation in clinical research means a shift from thinking about the patient to thinking with the patient. This means that patients are giving feedback about the study, sharing their concerns, and providing input on specific areas like visit...
In this issue of The Altascientist we provide a detailed overview on the different goals and challenges that are presented by the validation of immunogenicity assays to support nonclinical and clinical studies, including a case study.
There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials.
There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials.
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...
Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21...
Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and...
Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their patients to the investigator. BBK Worldwide’s Study Voices survey challenges the myth, invoking a...
In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of pharmaceutical professionals, including sponsor companies as well as contract research, development,...
When planning a clinical trial, overlooking the importance of primary packaging can be a mistake. From stability concerns to labeling to patient compliance or the ability to use the same packaging in multiple countries, poorly informed decisions...
Chazy, New York is located only six miles from the Canadian Border in Upstate New York. It is only ten minutes North of Plattsburgh, one hour south of Montreal, Quebec, Canada, and one hour west...
Two of the biggest challenges in today’s global clinical trials are patient recruitment and retention. These problems often spring from clinical trial supply logistical issues — patients...
Pharmaceutical fluid transfer involves many tubing-to-fitting connections, and unfortunately those connections can leak and result in contamination, production delays, lost income and headaches....
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...