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PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing _ NorthEast BioLab

A pharmacokinetic (PK) investigation of another medication includes taking a few blood tests throughout some stretch of time from concentrate on members to decide how the body handles the substance. These examinations give basic data about new medications. We perform PK Study in clinical preliminaries to analyze the retention, circulation, digestion, and discharge of a medication. These investigations are valuable for deciding the suitable portion range for wellbeing and viability in resulting preliminaries.

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PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing _ NorthEast BioLab

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  1. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Search Home Pharmacokinetics (PK) Study Assay Services Lab CRO Robust Pharmacokinetics (PK) Assay Services For Your Clinical Trials And Preclinical PK Study! FDA Audited PK Assay Services To De-Risk And Enhance Your Drug Portfolio Accelerated PK Assay Development And Validation Since 2003 SAD MAD PK Clinical Trials Study For Your Drug And Metabolites GLP PK Bioanalysis Using Fully Validated LC-MS/MS or ELISA Assays Provide Your Bioanalysis Study Details We Will Contact You Within 1 Business Day First Name* Last Name Email* Phone https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 1/11

  2. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists How Can We Help You?* Include Details, Such As Test Article, Bioanalytical Method, # Of Samples, GLP/Non-GLP, Etc. REQUEST QUOTE Search SPEAK TO OUR SCIENTISTS Click Below For Answers To Your Pharmacokinetics (PK) Study Questions - What is a Pharmacokinetic (PK) Study? When is PK Analysis performed during Drug Development? Which PK Assay and PK Analysis Services do we Offer? Why Choose us for your Pharmacokinetics (PK) Study? PK Assay Services CRO Trusted By Biotech Over 15+ Years! PK Assay Analysis Services At Industry-Leading Turnaround Tailor-Made, High-Value PK Study Assay Services For Biotech Full-Service PK Testing From GLP Preclinical Method Development To Clinical Trial Sample Analysis PK Bioanalysis Services For Small Molecules, Peptides, mAbs, etc SPEAK TO OUR SCIENTISTS https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 2/11

  3. 12/10/21, 6:32 PM What Is A Pharmacokinetic (PK) Study? Email Your Inquiry PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab sales@nebiolab.com (203) 361 3780 Speak to Our Scientists Pharmacokinetics (PK) Study: Drug Concentration vs. Time in the Body REQUEST QUOTE A pharmacokinetic study provides the basis for determining drug exposures in the body over time. PK parameters are used in the evaluation of the absorption, distribution, metabolism, and excretion (ADME) processes of drugs. Search Absorption Absorption, the first topic of PK studies, is the initial process by which drugs enter the blood circulation following dosing. Drug substances in PK lab testing can be administered to the body through several routes such as oral, nasal, dermal, or parenteral. Absorption at the gastrointestinal tract, one of the most common drug absorption sites, is affected by several factors including physicochemical parameters of the drug, gastrointestinal motility, drug concentration, and ionization state at the site of absorption. Distribution Distribution is a reversible drug transfer within the body from one location to another. The distribution of a drug can be influenced by several factors such as lipid-solubility, concentration in plasma and various tissues, and protein binding of drugs in plasma and tissues. PK studies assess whether compounds can distribute throughout the body readily or are confined to the bloodstream once absorbed. Metabolism Metabolism, an essential topic of PK analysis, is the process by which a drug is converted to another chemical entity (metabolite). Metabolism happens primarily in the liver and is classified into two broad categories: Oxidative metabolism includes hydrolysis, oxidation, and reduction reactions driven mainly by the cytochrome P450s, monooxygenase systems, and alcohol dehydrogenases. The typical chemical reactions involved in oxidative metabolism include aromatic hydroxylation, aliphatic hydroxylation, oxidative N dealkylation, oxidative O-dealkylation, S-oxidation, reduction, methylation, and hydrolysis. Most often, these reactions increase compound polarity to make a drug more soluble, facilitating elimination through the kidneys. In conjugative metabolism, conjugation occurs by glucuronidation, sulfation, amino acid conjugation, acetylation, or glutathione conjugation to aid elimination. Enzymes involved in conjugation include UDP glucoronyl transferases, aryl sulfatases, N-acetyl transferases, and glutathione S-transferases. Conjugation can serve to inactivate a compound or make it more readily eliminated by urinary or biliary excretion. Several factors influence a drug’s rate of metabolism, including the route of administration, dose, genetics, disease state, and metabolic activity. Excretion Eliminating the drug and other toxic substances from the body, the last topic of the PK study, is known as the process of excretion. Most drugs in the body are eliminated through the urine. Excretion also depends on the solubility of the drug in water. More soluble drugs are excreted faster in the urine. If the excretion is incomplete, the accumulation of compounds in the body can lead to adverse events. https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 3/11

  4. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab Pharmacokinetics study testing should incorporate sufficient sampling times during compound elimination for appropriate assessments of parameters such as elimination half-life and clearance. Email Your Inquiry sales@nebiolab.com (203) 361 3780 Speak to Our Scientists REQUEST QUOTE What Our Sponsors Have To Say? Search VP, PK Top 10 Pharma Executive Director, Drug Researc Biotech Our projects with NorthEast BioLab include method development, stability studies, cross- validation of other labs, support for investigator- sponsored studies, and Clinical Phase I – IV studies. They have considerably exceeded our expectations time and again. NorthEast BioLab provided critical insight into analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend them and look forward to working together in the future. ‹ › Ready To Take The First Step? Consult with a Scientist About Your PK Study Assay Services Lab SPEAK TO OUR SCIENTISTS When is PK Analysis Performed During Drug Development? PK Analysis: From Drug Discovery and Preclinical to Clinical Phases PK analysis is performed throughout the drug research and development process, starting from early discovery to the last Phase of drug development. The primary purpose of preclinical pharmacokinetic studies is to evaluate the characteristics of potential drugs to predict exposures and determine dose https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 4/11

  5. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab levels and frequencies for testing new chemical entities in preclinical disease efficacy models. PK studies in multiple species can be used to predict human pharmacokinetics and estimate the dose required for clinical efficacy and potential manufacturing costs for the intended drug product after achieving therapeutic proof-of-concept and honing structure-activity-relationships (SAR) to determine lead molecules. Pharmacokinetic (PK) Assays during the preclinical phase help determine bioavailability, the volume of distribution, half-life, and clearance. These PK studies help evaluate if the drug has adequate success potential or needs to be modified to improve its pharmacokinetic parameters. Pharmacokinetic (PK) study results from the preclinical stage help design IND enabling Tox studies in animals, and drugs can be advanced farther into clinical development based on these preclinical results. PK bioanalysis meeting the requirements for first in human (FIH) dosing initially undergo single ascending dose (SAD) clinical trials to assess the safety and clinical pharmacokinetics, followed by later multiple ascending dose (MAD) clinical trials to assess steady-state exposures and to correlate with drug pharmacology. sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Search https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 5/11

  6. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Search Introduction To Pharmacokinetics Pharmacokinetics (PK) is the analysis and description of the disposition of a drug in the body, encompassing development of the mathematical description of all dispositional processes in the body, defined as ADME – absorption, distribution, metabolism, and elimination… READ MORE AT OUR LEARNING CENTER https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 6/11

  7. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists Which PK Assay and PK Analysis Services Do We Offer? REQUEST QUOTE PK Assay and PK Analysis Services by NorthEast BioLab Search We offer a wide range of Pharmacokinetic (PK) Assays beginning from the early discovery phase when a potential drug compound is administered to rodents for understanding ADME properties. Once a compound is found suitable for further development, we also provide Pharmacokinetic (PK) testing services for dose range finding studies followed by IND enabling Toxicology (Tox) studies in rodent and non-rodent animals. PK studies in animals are critical for safely advancing the drug into clinical development. We provide pharmacokinetics services during clinical trials by developing and validating bioanalytical methods in the human biological matrices post the FDA approval of your IND application. Once your PK bioanalysis is completed, we can complete your Pharmacokinetics (PK) study by calculating relevant parameters for your compound. Additionally, we are glad to assist you with protocol and study design, study execution, and interpretation of your PK data, and/or provide guidance on compound selection, dose levels, collection intervals for preclinical efficacy testing. We maintain fully validated Phoenix WinNonlin software at our facility for non-compartmental analyses (NCA) and PK modeling. Our team can generate formally audited bioanalytical reports for all your regulated studies from early discovery through clinical development. Registered and Inspected by Various Regulatory Agencies Why Choose Us For Your Pharmacokinetics (PK) Study? Accurate Pharmacokinetics (PK) Study to Assess your Drug’s Proper Exposure and Therapeutic Potential https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 7/11

  8. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab Pharmacokinetics studies for ADME and toxicokinetic analysis demand both in-depth expertise and nimble execution. NorthEast BioLab is the right partner to assist you in bringing new, effective drugs to the market given the critical and detail-orientated nature of these PK studies in pharmaceutical drug development. sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Our team of veteran scientists can help discern your top drug compound based on our 15+ years of experience in method development, validation, transfer for PK bioanalysis and related assay. Together, we can develop robust bioanalytical methods to support your PK studies for the analysis of drugs and metabolites in biological fluids followed by the calculation of PK parameters by non-compartmental analysis (NCA). We promise a high quality and take full responsibility for all your projects, including compliance with various regulations mandated by authorities and agencies such as FDA and ICH. Search You can de-risk your drug portfolio right away by leveraging our FDA audited Pharmacokinetics (PK) Study Assay, Testing, And Sample Analysis Services offered to premier biotech/pharma since the early 2000s. We regularly conduct SAD MAD Pharmacokinetics (PK) Studies to determine drug behavior in the body and facilitate critical decision-making on dosage and safety. Our scientists generate and model your GLP PK bioanalysis data using fully validated assay and WinNonlin software. Speak to our Scientists to get started on your first PK Assay with us. Still Have Questions Regarding Your Pharmacokinetics (PK) Study Assay Services Lab CRO? The Scientists At NorthEast BioLab are Ready to Help! SPEAK TO OUR SCIENTISTS Related FAQs Answers to additional Pharmacokinetics (PK) Study questions popular among our potential clients. What does PK stand for in clinical trials? What is the main purpose of PK testing? https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 8/11

  9. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab How do you perform a pharmacokinetic study? sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists What is the importance of pharmacokinetics analysis in drug development? REQUEST QUOTE What are the four major components of pharmacokinetics study? Search What is the difference between pharmacokinetics and pharmacodynamics? What are pharmacokinetic (PK) parameters? Explore More Services Pharmacokinetics (PK) Study Toxicology (Tox) Study Biomaker Testing Services Bioequivalence and Bioavailability Studies Immunogenicity Testing Bioanalytical Assay Expertise https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 9/11

  10. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists Services REQUEST QUOTE Solutions Search About Us Resources Consult with a Scientist Now We Will Contact You Within 1 Business Day First Name* Last Name Email* Phone How Can We Help You?* Include Details, Such As Test Article, Bioanalytical Method, # Of Samples, GLP/Non-GLP, Etc. SPEAK TO OUR SCIENTISTS 925 Sherman Avenue Hamden, CT 06514 sales@nebiolab.com (203) 361 3780 https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 10/11

  11. 12/10/21, 6:32 PM PK Assay Analysis Services, Pharmacokinetics (PK) Study, PK Testing | NorthEast BioLab (203) 361 3780 sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Search Privacy Policy Terms of Use Sitemap © 2019 - 2025, NorthEast BioAnalytical Laboratories LLC. All rights reserved. https://www.nebiolab.com/clinical-pharmacokinetics-pk-study/ 11/11

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