Pharmacokinetic Study provides the basis for identifying drug absorption, distribution, metabolism, and excretion. During drug research and development, PK studies are first carried out in rodent and non-rodent animal models to form the basis of clinical pharmacokinetics sample testing.
Absorption, the first part of PK studies, is the process by which drugs enter into blood circulation. Generally, drug substances can enter the body through several channels such as digestive tract, nasally, dermally, or parenterally. Numerous pharmacokinetics clinical trials test the gastrointestinal tract as one of the most common drug absorption sites. Absorption is affected by multiple drug parameters - physicochemical factors, concentration, and gastrointestinal motility, etc.
Distribution is a reversible transfer of medicine within the body from one location to another. Distribution gets influenced by several factors such as the drug solubility in lipids, concentration in plasma and tissue, and protein binding in plasma. PK studies and testing in clinical trials help capture this crucial PK data.
An essential part of PK analysis, metabolism is the pharmacokinetic process of drug transformation into metabolites. Clinical pharmacokinetics studies consider the metabolism that happens primarily in the two stages within the human liver. In Phase I metabolism, a group of enzymes called Cytochrome P450 catalyze the reactions in the microsomes. Typical chemical reactions in this phase are aromatic hydroxylation, aliphatic hydroxylation, oxidative N dealkylation, oxidative O-dealkylation, S-oxidation, reduction, and hydrolysis. Often this functionalization is enough to make a drug more soluble, facilitating elimination through the kidneys. In Phase II metabolism, conjugation occurs by glucuronidation, sulfation, amino acid conjugation, acetylation, methylation, or glutathione conjugation to aid elimination. Ultimately, several factors influence drug metabolism, including the route of administration, dose, genetics, disease state, and metabolic activity.
Elimination of the drug and other toxic substances from the body, the last part of the PK study, is known as excretion. Majority of the drugs in the body get eliminated through the urine. Naturally, excretion then depends on the water solubility of the drug. More soluble drugs are excreted faster through the urine. Among other things, a PK clinical trial studies the extent of drug excretion as the accumulation of compounds in the body can hurt metabolism.
PK Analysis during Drug Discovery, Preclinical, and Clinical Phases
PK analysis carried throughout the drug R&D, from early discovery to the late phases of PK clinical trials, is required to generate relevant pharmacokinetic data. The primary purpose of preclinical PK sample analysis is to evaluate essential drug characteristics for human pharmacokinetics testing. For example, PK Assays during the preclinical phase determine the drug bioavailability, distribution volume, half-life, and clearance. Similarly, preclinical PK study results help design IND enabling Tox studies in animals. Sequentially, the drugs can be advanced farther into clinical development based on these preclinical PK data. Pharmacokinetic studies help evaluate drug potential or need to improve PK parameters.
Which PK Assay does NorthEast BioLab Offer?
We offer a wide array of PK Assay beginning from the early discovery phase when a potential drug is administered to rodents for understanding ADME properties. Our Non-GLP DMPK capabilities include Plasma protein binding, Microsomal stability, and CYP450 inhibition studies. Once ready for further drug development, we provide PK assay sample analysis for dose range-finding toxicity studies followed by IND enabling repeat dose toxicity and toxicokinetic studies in rodent and non-rodent animals. These GLP PK studies in animal models are critical for advancing your drug into clinical development. Lastly, we offer clinical pharmacokinetics during clinical trials by developing and validating bioanalytical methods in the human matrices after FDA approval of your IND application.
Why Choose Northeast BioLab for your Pharmacokinetics (PK) Study?
Getting pharmacokinetics studies, such as ADME, toxicity, and toxicokinetic testing, right in the first time demands a unique combination of in-depth expertise and nimble execution from your bioanalysis lab. Given our exemplary track record with these critical and detail-orientated PK studies, NorthEast BioLab is the right partner in bringing your new, more effective therapies to the market.
Our team of veteran scientists can help discern your top drug compound based on our 15+ years of experience in bioanalytical method development, validation, transfer for PK sample analysis, and related assay. Following each project, we prepare a comprehensive PK data report fully audited by our QAU in compliance with various regulations by agencies such as FDA and ICH. Together, we would steadfastly navigate through your PK clinical trials by closely collaborating on multiple PK studies.
In summary, try us once based on our reputation, and we would likely partner endlessly given our dedication to high quality and full responsibility towards all your projects.