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EXPLORE MORECreative Biolabs has a tradition of commitment. To achieve efficient execution and regulatory approval, we offer careful considerations of your program for the development of a cellular or gene therapy product – now and in the future.
EXPLORE MORE HighlightsWe focus on unmet needs and develop novel cellular and gene drugs and solutions that offer significant benefits over existing options.
EXPLORE MORE HighlightsTo accelerate advanced breakthroughs of your projects, we offer broad range of platforms which enable our clients be free to tackle problems with cutting-edge technologies from different angles and in different methods.
EXPLORE MORE HighlightsUse the resources in our library to help you understand your options and make critical decisions for your study. We offer oncolytic virus, CAR-T, and dendritic cell related documents, as well as newsletter. If you don't find the answers you're looking for, contact us for additional assistance.
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All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.
Optimal drug therapy is predicated on selecting the most appropriate patient-specific pharmacological intervention at an individualized dose, and at the right time in the patient's disease process. A reliable pharmacokinetic (PK) biomarker is one important parameter that is critical to assure correct patient selection, drug dosing, and monitoring for safety and efficacy of many therapies in clinical practice. Creative Biolabs has a decade of experience in PK assays to support our clients' research on large molecules through all phases of assay development, validation, and testing. Our scientists are specialized in complex PK biomarker evaluation method development and protocols to facilitate drug discovery and clinical trial programs. By leveraging the wealth of information that we have on PK biomarker evaluation, our scientists will assist our clients in developing a strategy that is suitable for their program development.
In the targeted therapy era, PK issues are responsible for the majority of drug-development failures. The growing emphasis on the incorporation of biomarkers into early clinical development programs is altering the PK strategies for the conduct of early clinical trials. PK biomarkers are now regarded as important critical tools to facilitate drug-development programs in a rational, hypothesis-testing fashion. These biomarkers can be used to empower intelligent decision-making and critically evaluate the reasons for the success or failure of a new drug in the clinic.
Creative Biolabs has extensive experience in developing and validating PK assays throughout the phases of the drug development process using diverse techniques including ELISA, fluorescence-activated cell sorting (FACS) analysis, quantitative polymerase chain reaction (qPCR), meso scale discovery (MSD) electrochemiluminescence (ECL) assay, liquid chromatography with tandem mass spectrometry (LC-MS/MS) and high-performance liquid chromatography (HPLC). Our scientists are specialized in the quantification of PK biomarkers in multiple specimen types including humans, non-human primates and rodents, and in a variety of tissue types including serum, urine, plasma, and saliva.
Creative Biolabs has a highly experienced team of scientists who have a long history of successful implementation of complex PK assays. Our PK assay data are scientific excellence and have been interpreted to gain a comprehensive understanding of the absorption, distribution, metabolism, and excretion characteristics of the drug tested. For more detailed information on our pharmacokinetic biomarker evaluation services, please feel free to contact us or directly send us an inquiry.
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