Blogs
Understanding the intricate relationship between drugs and the human body is crucial for effective medical treatments. Two fundamental concepts in pharmacology – pharmacokinetics and pharmacodynamics – play pivotal roles in this understanding. This blog post will delve into these concepts, exploring their differences and significance in drug development and clinical…
Blogs
What is a generic PK assay? A generic pharmacokinetic (PK) assay, also referred to as a universal PK assay for New Biologic Entities (NBE), is used to measure circulating human biotherapeutics—primarily antibody-based—post-administration across various non-human matrices. These assays are particularly beneficial when drug-specific reagents, such as anti-idiotype antibodies, are…
Blogs
When you examine how to develop and validate/qualify a Biodistribution assay by PCR…
Blogs
The Role of Pharmacokinetics (PK) in Drug R&D Pharmacokinetics (PK) is defined as the study of the fate of a new therapeutic entity (NTE) after it is administered into the body of animals or humans. It involves understanding how the drug is absorbed, distributed, metabolized, and eliminated (ADME). Essentially, PK…
Podcasts
Our hosts, Dom and John, are excited to welcome special guest, Carrie Vyhlidal, to discuss the topic of the 80th episode of “The Weekly Bioanalysis” podcast – The Rapid Evolution of PCR Assays. PCR (or Polymerase Chain Reaction) is like a copying machine for DNA. Scientists have found ways to…
Blogs
Ligand binding assays (LBAs) have been our core activity for decades. LBAs are commonly used to measure interactions between two proteins, a ligand and its receptor, a monoclonal antibody (mAb) and its target, or biologics and Anti-Drug Antibodies (ADA). Throughout the development of New…
Blogs
With recent guidance released from the FDA, there are changes for PKs (Pharmacokinetics) and ADCs (Antibody Drug Conjugates) that must be clearly understood before making decisions for your drug product testing. ADCs combine the target specificity of monoclonal antibodies with the…
Blogs
Clinical research carries significant risks and numerous obstacles that must be overcome to achieve success. Identifying the ideal Contract…
Podcasts
In the world of bioanalysis, pharmacokinetics is a key step in the process of measuring and identifying elements of the drug. It is a baseline for sample analysis, and in episode 67 of “The Weekly Bioanalysis”, Dom and John discuss the history and evolution drug and pharmacokinetic modalities…
Podcasts
Special guests Dawn Duffield, PhD of KCAS and Barry Jones, PhD of Crinetics join John and Dom in the 66th episode of “The Weekly Bioanalysis” to discuss the ways Hybrid LC-MS/MS has advanced in recent years and how the technology has gone from “new” and somewhat obscure to…
Blogs
ICH M10 (International Committee of Harmonization Multidisciplinary guideline) provides guidance on bioanalytical method validation and study sample analysis for the measurement of chemical and biological human drugs and their metabolites in biological samples. Such pharmacokinetic/toxicokinetic data serve as the basis for regulatory decisions on the safety, dosage, and…
Blogs
In 2022 we had 42 FDA Drug Approvals and 3 were Gene Therapies using a viral vector. 2 of the approvals in 2022 were AAV based. The third is manufactured by adding functional copies of the transgene to the patient’s own Hematopoietic Stem Cells (HSCs)…