Bioanalysis
Making Early-Phase Drug Development Faster, Better, and More Efficient
Early-phase drug discovery and drug development are complex processes, where many moving parts can, and do, influence the success of a program.
Leveraging the Benefits of Microsampling for Safety and Convenience
In a previous blog, we provided an overview of microsampling technology for preclinica
Q&A Session with Dr. Danielle Salha
Renowned for our full-service offering, we often get asked — how does Altasciences manage the development process for biologics and biosimilars so seamlessly from the require
ISSUE NO. 16 — Microsampling in Drug Development
Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic drugs, metabolites, and biomarkers in preclinical and clinical research.
In preclinical research, microsampling technology supports the 3Rs of animal research, and allows for less intrusive blood collection procedures.
By definition, clinical microsampling reduces sample volume to less than or equal to 50 microlitres (μL) compared to conventional venipuncture wherein millilitres (mL) of blood volume is collected. In Altasciences’ experience, microsample volumes being analyzed are less than or equal to 20 μL, with some microsampling techniques as low as 5 μL.
In Issue 16 of The Altascientist, we explore the benefits, applications, and considerations of microsampling in preclinical, clinical, and bioanalytical research, including:
- regulatory considerations
- case study: Anti-Epileptic Drug Monitoring – Sample Preparation Using Impact-Assisted Extraction
- case study: Large Molecule – Determination of Rituximab Using a Surrogate Peptide Approach
2020 Year in Review
2020 has been quite a year! Each year, we strive to provide you with a more innovative, simplified, and seamless early phase drug development journey. And the past 12 months have been no exception.
Up Close and Personal with Dr. Lynne Le Sauteur, PhD
.custom-column-left-text {
float: left;
width: 50%;
padding-right: 10px;
}
.custom-column-right-text {
float: right;
width: 45%;
text-align:center;
}
@media only screen and (max-width: 600px) {
.custom-column-left-text,
.custom-column-right-text,
.custom-column-flc-ebook-text {
float:none;
width:80%;
margin:0 auto;
}
}
Dr. Determination of Normal: Flow Cytometry Analysis of Major Immune Cell Populations in Peripheral Blood of Naïve Cynomolgus Monkeys
Assessment of Receptor Occupancy via Flow Cytometry: Benefits and Pitfalls of Two Common Approaches
Rigorous Sample Handling Processes
.custom-column-left-text {
float: left;
width: 50%;
padding-right: 10px;
}
.custom-column-right-text {
float: right;
width: 45%;
text-align:center;
}
@media only screen and (max-width: 600px) {
.custom-column-left-text,
.custom-column-right-text,
.custom-column-flc-ebook-text {
float:none;
width:80%;
margin:0 auto;
}
}
Regulatory GuidanceEnsuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical tria Get Up Close and Personal with Dr. Anahita Keyhani, PhD
.custom-column-left-text {
float: left;
width: 50%;
padding-right: 10px;
}
.custom-column-right-text {
float: right;
width: 45%;
text-align:center;
}
@media only screen and (max-width: 600px) {
.custom-column-left-text,
.custom-column-right-text,
.custom-column-flc-ebook-text {
float:none;
width:80%;
margin:0 auto;
}
}
Dr. Anahita Keyhani is Altasciences' Senior Director of Scientific Operations, Mass Spectrometry and Method Development. |