BOC Sciences is committed to providing global partners with a top DMPK research service platform to help customers quickly advance the drug development process. We provide a full range of services covering in vitro ADME experiments and in vivo PK studies in animals from drug discovery to new drug filing. During the preclinical drug development phase, we combine pharmacology and toxicology expertise to provide comprehensive DMPK services that meet regulatory requirements to support clients' Investigational New Drug (IND) filings.
Drug metabolism and pharmacokinetics (DMPK) studies can be performed throughout the drug development process to help define the pharmacological profile of a drug candidate by focusing on its absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic properties.
Drugs are broken down or metabolized by organisms into other related compounds, usually by specialized enzymatic systems. Metabolite identification is critical for drug metabolism studies by determining the formation of metabolites in in vitro or in vivo studies to interpret pharmacological, pharmacokinetic, and toxicological data.
Pharmacokinetics is the study of how an organism affects a drug. ADME helps explain the PK course of a given drug. Understanding the ADME properties of a drug is critical for developing safe and effective drugs.
DMPK studies allow characterization of the ADME properties of drugs early in development, providing critical information such as drug-drug interactions. Fundamental information obtained in regulatory DMPK studies can help guide drug development and determine the appropriate dose for actual use of drug candidates. Regulatory DMPK throughout the development process can assess the safety or efficacy of a drug, which can ultimately improve its likelihood of success in clinical studies and real patients. A clear understanding of a drug's DMPK profile is critical for regulatory agencies to understand a drug's safety, efficacy, and other factors relevant to patient use.
Our regulation of DMPK covers the entire stage of drug discovery, including but not limited to:
BOC Sciences provides Good Laboratory Practice (GLP) compliant chemical analysis and bioanalytical services to support drug discovery and development services ranging from highly potent active pharmaceutical ingredients (HPAPIs), small molecule drugs to large molecule biologics, vaccines, biomarkers and more. In addition, we develop in vivo and in vitro technologies for DMPK studies and quality studies. Our regulatory DMPK services are dedicated to expediting regulatory approvals and helping clients deliver safe drug products faster.