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| Your World Class Partner in DMPK |
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1. Drug Metabolism and Pharmacokinetics (DMPK) |
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| One of the major areas in which HD Biosciences serves the pharmaceutical industry is Drug Metabolism and Pharmacokinetics (DMPK). HD Biosciences maintains state-of-the-art bioanalytical facilities. The scientific staff that oversees these operations is very experienced in DMPK. The goal of the HD Biosciences DMPK group is to fully serve its Sponsors in fulfilling their DMPK needs. |
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| Pharmacokinetics |
HD Biosciences scientists are experts in designing, performing, and interpreting the results of pharmacokinetic studies. Study design and selection of the appropriate model to be used are often customized to meet the project needs. Surgical preparations can be performed, if required. For example, pharmacokinetic study samples might include blood, bile, or other matrices, as well as tissue or tumor specimens that have special bioanalytical requirements. Analysis of pharmacokinetic samples is typically performed using LC/MS/MS. HD Biosciences performs pharmacokinetic studies in rodent and non-rodent species for projects at the discovery screening stage (rapid turnaround), IND-enabling studies, as well as toxicokinetic studies. |
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SPF Animal Barrier Facility
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| Protein Binding |
| Plasma protein binding can greatly influence the tissue distribution, clearance, and pharmacological effects of drugs. HD Biosciences performs discovery stage plasma protein binding assays, as well as more thorough studies for regulatory submissions and clinical samples, usually using equilibrium dialysis or ultrafiltration. Analysis of protein binding samples is typically performed using LC/MS/MS methods. |
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| In Vitro Metabolism |
| HD Biosciences provides a full range of in vitro and ex vivo assays utilizing microsomes, S9 fractions, or hepatocytes from multiple species, to study drug metabolism. Microsomal stability is commonly used as a discovery tool to predict the extent of hepatic first-pass metabolism. At later stages, it is important to minimize the potential of clinical drug-drug interactions between drug candidates and co-medications. The CYP inhibition potential of new drug candidates can be assessed using a rapid, reliable, and specific CYP inhibition screening method HD Biosciences has developed. This method measures activities of six major human CYP isozymes (CYP1A2, 2B6, 2C9, 2C19, 2D6, and 3A4) using selective substrates incubated with human liver microsomes. |
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| Metabolite identification |
| Utilizing the strengths of bioanalysis, LC/MS/MS, and NMR for metabolite identification studies are routinely performed. The goal is to define metabolic pathways for new drug candidates. The studies are often performed in conjunction with mass balance excretion studies, using plasma, urine, or bile samples from mice, rats, dogs, monkeys, or humans. Metabolite identification studies can also be performed in vitro using liver microsomes, hepatocytes, or other preparations from humans or animal species. |
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| Mass Balance |
| An excretion mass balance study can provide fundamental information about the rates and routes of elimination of a new drug candidate. Mass balance studies are often an important component of regulatory submissions. HD Biosciences performs various mass balance studies in mice, rats, dogs, and monkeys. Typically, a radiolabeled drug is administered intravenously and/or orally, and excretion of radioactivity is monitored in urine, feces, and occasionally bile and expired air. In addition to providing information on the relative rates of excretion in urine and bile, these studies can indicate the percentage of an oral dose systemically absorbed. Further information can be obtained by analyzing mass balance study samples for parent drug and individual metabolites using LC/flow scintillation detection or LC/MS/MS to find out routes of elimination of parent compound and its metabolites. HD Biosciences also has capabilities for chemical synthesis if authentic samples of metabolites are required to complete such projects. |
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| 2. Bioanalytical |
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| Strong scientific and regulatory knowledge combined with method development experts and experienced scientists who understand your needs for timely and accurate communication allows HD Biosciences to offer extensive bioanalytical services from discovery stage through clinical studies. HD Biosciences offer method development and validation to support preclinical and clinical studies. |
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| The focus of bioanalysis is to provide a quantitative measure of the active drug and/or its metabolite(s). Samples may be derived from cell culture media or from other biological matrices (plasma, serum or urine etc). An appropriate bioanalytical technique is required for the measurements. Selection of the correct technique may depend on the molecule's chemical nature, molecular weight, and structure. |
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