Regulatory DMPK
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Regulatory DMPK

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.

Introduction of DMPK

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.

  • Drug metabolism

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 (PK)

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.

  • Absorption: Factors that affect the rate and extent of drug absorption include the chemical properties and formulation of the drug, route of administration, interactions with food / drugs, etc.
  • Distribution: The movement of a drug from tthe absorption site to tissues around the body may be influenced by many factors, such as blood flow, lipophilicity, molecular size, and how the drug interacts with the components of blood.
  • Metabolism: Metabolism can occur in many parts of the body, with most metabolism taking place in the liver. Cytochrome P450 (CYP450) enzymes are responsible for the biotransformation or metabolism of approximately 70-80% of drugs in clinical use. CYP-mediated drug metabolism facilitates drug clearance from the body.
  • Excretion: Renal excretion into the urine is one of the most important drug clearance mechanisms. If the drug is not excreted normally due to renal insufficiency, accumulation and potential toxicity of the drug in the body may occur.

The Importance of Regulatory DMPK

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 Regulatory DMPK Services

Our regulation of DMPK covers the entire stage of drug discovery, including but not limited to:

Regulatory DMPK

In vitro

  • PAMPA/in-situ permeability
  • Metabolite profiling
  • Hep G2 hepatotoxicity
  • Cytotoxicity in suitable cell line
  • CYP450 inhibition/induction
  • In vitro ADME studies

In vivo

  • Tissue distribution
  • Excretion studies (e.g. urine, feces and bile)
  • CYP 450 reaction phenotyping
  • Anmial PK (in rodent and non-rodent)
  • Toxicokinetics (e.g. 28 day repeat dose toxicity studies in rats

Our Advantages

  • Comprehensive DMPK service portfolio
  • Ensure high-quality data is submitted in an efficient manner
  • Experienced research team and advanced technologies
  • Data modeling and analysis, detailed results reporting and discussion
  • Work closely with customers
  • Highly reliable and repeatable data
  • Cost-effective solution

What Can We Do?

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.