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MicroConstants

San Diego, California, US

MicroConstants is a GLP-compliant Contract Research Organization focused on performing regulated bioanalysis, drug metabolism and pharmacokinetic analysis in support of discovery, preclinical and clinical drug development studies. We specialize in method development, validation and sample analysis for small molecules, macromolecules, biomarkers and metabolites using LC/MS/MS, HPLC/UV, immunoassay, multiplex and qPCR techniques. MicroConstants also assembles and distributes protocol-specific specimen collection kits to streamline and simplify the PK collection process for single and multi-site clinical trials.

MicroConstants, Inc. was founded in 1998 in San Diego, California by Gilbert Lam, Ph.D., a veteran in pharmaceutical development and a scientist trained in the field of pharmacokinetics. Our San Diego facility has since grown to become one of the largest bioanalytical LC/MS/MS laboratories on the West Coast of... Show more »

MicroConstants is a GLP-compliant Contract Research Organization focused on performing regulated bioanalysis, drug metabolism and pharmacokinetic analysis in support of discovery, preclinical and clinical drug development studies. We specialize in method development, validation and sample analysis for small molecules, macromolecules, biomarkers and metabolites using LC/MS/MS, HPLC/UV, immunoassay, multiplex and qPCR techniques. MicroConstants also assembles and distributes protocol-specific specimen collection kits to streamline and simplify the PK collection process for single and multi-site clinical trials.

MicroConstants, Inc. was founded in 1998 in San Diego, California by Gilbert Lam, Ph.D., a veteran in pharmaceutical development and a scientist trained in the field of pharmacokinetics. Our San Diego facility has since grown to become one of the largest bioanalytical LC/MS/MS laboratories on the West Coast of the United States, housing 15 LC/MS/MS systems and occupying 34,000 square feet of office and laboratory space.

In 2007, MicroConstants expanded its operations internationally when Dr. Lam co-founded MicroConstants China Inc. in Beijing, China. The second facility was established to meet the growing demand of pharmaceutical development being outsourced to Asia. MicroConstants China adopted MicroConstants' quality systems, has been GLP-compliant since April 2009, and all key personnel participated in extensive cross-Pacific training.

MicroConstants’ laboratories in San Diego and Beijing are both fully compliant with USFDA, OECD, and MHLW Good Laboratory Practice (GLP) guidelines.

MicroConstants is dedicated to becoming the recognized leader in regulated bioanalysis, drug metabolism and pharmacokinetic analysis. We understand that the only way to achieve this goal is by providing our pharmaceutical and biotech partners with the highest quality data, exceptional client services, state-of-art equipment, and a team of skilled professionals. Our success is intertwined with that of our clients’; therefore we constantly strive to meet our customers’ needs, exceed their expectations, and continually expand our contract research services to help advance our clients’ drug discovery and development programs.

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MicroConstants has not listed any services.

Blood to Plasma Ratio
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MicroConstants performs blood-to-plasma partition ratio studies to determine the blood-to-plasma ratio for test articles. Knowing the distribution of a drug candidate between red blood cells and plasma is useful for a number of reasons, including the explanation of variability in measured plasma concentrations due to hemolysis.... Show more »

MicroConstants performs blood-to-plasma partition ratio studies to determine the blood-to-plasma ratio for test articles. Knowing the distribution of a drug candidate between red blood cells and plasma is useful for a number of reasons, including the explanation of variability in measured plasma concentrations due to hemolysis. Additionally, compounds that preferentially distribute into red blood cells may have over-predicted clearance values based on plasma concentrations. Therefore, determining the blood-to-plasma ratio is important for deciding whether plasma or whole blood would provide more physiologically relevant pharmacokinetic parameters. For these studies, chloroquine is used as a positive control.

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In vitro Drug-Drug Interaction Studies
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Drug-Drug Interaction Studies (CYP/UGT induction, inhibition & identification)

One of the concerns of developing new pharmaceutical candidates is how the compound will interact with co-administered medications. These drug-drug interactions result in different pharmacokinetic profiles and may lead to an adverse event or... Show more »

Drug-Drug Interaction Studies (CYP/UGT induction, inhibition & identification)

One of the concerns of developing new pharmaceutical candidates is how the compound will interact with co-administered medications. These drug-drug interactions result in different pharmacokinetic profiles and may lead to an adverse event or loss of efficacy for either the candidate or the marketed medicine. We offer a range of in vitro services to evaluate the potential for drug-drug interaction, including cytochrome P450 (CYP450) induction studies, CYP/UGT inhibition studies, and CYP/UGT reaction phenotyping.

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Metabolite Identification
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We identify metabolites in profiling studies, or characterize impurities in your API, using accurate mass spectrometry (QTof Premier) with collision cell optimization. Samples are generated either in vivo or in vitro. A metabolite standard may also be supplied for comparison of the retention time and product ion spectra with those of the postulated metabolite.

We identify metabolites in profiling studies, or characterize impurities in your API, using accurate mass spectrometry (QTof Premier) with collision cell optimization. Samples are generated either in vivo or in vitro. A metabolite standard may also be supplied for comparison of the retention time and product ion spectra with those of the postulated metabolite.

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Metabolite Profiling
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We are able to generate and compare metabolite profiles to assist with species selection for toxicology studies. These studies are performed using accurate mass spectrometry (QTof Premier) to analyze samples from metabolic stability assays or in-life dosing studies. We search the data sets for potential metabolites (using... Show more »

We are able to generate and compare metabolite profiles to assist with species selection for toxicology studies. These studies are performed using accurate mass spectrometry (QTof Premier) to analyze samples from metabolic stability assays or in-life dosing studies. We search the data sets for potential metabolites (using Metabolynx XS), and compare the time profiles of parent compound loss and metabolite formation using enzyme sources from various animal species. Metabolite profiling studies can also be specifically designed to look for unique or disproportionate human metabolites.

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In vitro Metabolic Stability Assays
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Metabolic stability assays are helpful when trying to determine the potential half-life of a compound when dosed to animals or humans. We determine the stability of a test article in a variety of enzyme sources, including: hepatocytes, liver microsomal preparations, hepatic cytosol, hepatic mitochrondrial fraction, hepatic S9... Show more »

Metabolic stability assays are helpful when trying to determine the potential half-life of a compound when dosed to animals or humans. We determine the stability of a test article in a variety of enzyme sources, including: hepatocytes, liver microsomal preparations, hepatic cytosol, hepatic mitochrondrial fraction, hepatic S9 fraction, and membrane preparations from recombinant bacteria or eukaryotic cells. The time points are customized for each project, and the deliverables include raw data, percent remaining, and half-life values.

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In vivo Protein Binding Assays
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Only unbound circulating drugs have access to targets and excretion pathways, therefore the binding of drug candidates to plasma proteins plays a significant role in efficacy, drug distribution, and establishing safety margins. For these reasons, pharmaceutical companies and regulatory agencies are interested in determining the... Show more »

Only unbound circulating drugs have access to targets and excretion pathways, therefore the binding of drug candidates to plasma proteins plays a significant role in efficacy, drug distribution, and establishing safety margins. For these reasons, pharmaceutical companies and regulatory agencies are interested in determining the extent of drug binding to plasma and/or tissue proteins early in the drug development process.

MicroConstants will measure the binding of test articles to plasma or tissue proteins using the following sequence:

  • Develop a specific and sensitive quantitative method
  • Validate the analytical assay in accordance with FDA guidelines (if desired)
  • Conduct a pilot study to determine the optimum methodology (equilibrium dialysis, ultrafiltration, or ultracentrifugation methods)
  • Perform the incubation, analysis, and calculations

Methods for Measuring Drug-Protein Binding

MicroConstants employs the following methods to determine unbound drug concentration in plasma, serum, or tissue:

  • Equilibrium dialysis
  • Ultrafiltration
  • Ultracentrifugation

The plasma or tissue sample is first spiked with the test article at one or more concentrations and then incubated with the appropriate matrix for a prescribed period of time; however, samples from clinical or toxicology studies can be used instead. The unbound concentration is then determined using one of the above mentioned assays followed by LC/MS/MS analysis. Equilibrium dialysis can be performed with the RED device or a Spectrum 20. Several concentrations can be used to calculate a dissociation constant, Kd.

Species and Isolated Proteins Available

We routinely measure and compare protein binding in plasma or serum from the following species:

  • Mouse, rat, rabbit, dog, monkey, and human
  • Hamster, guinea pig, and mini pig can be used if commercially available

Protein binding can also be assessed for individual proteins such as:

  • Human serum albumin
  • Human α1-acid glycoprotein
  • Human sex hormone binding protein

Protein Binding Study Options

Depending on your study needs, we will perform:

  • Submission-Quality Studies - exhaustive studies to generate protein binding data suitable for regulatory submissions
  • Screening Assays - assays to filter lead compounds and estimate protein binding values early in the discovery process

Submission-Quality Studies

A pilot study is conducted to determine which methodology (equilibrium dialysis, ultrafiltration, or ultracentrifugation) is most appropriate for the measurement of the unbound test article. During this study we will assess stability in plasma at 37ºC, non-specific binding to the apparatus, and the estimated protein binding ratio. The results from these assessments will allow us to select the method best suited to provide robust results for the test article.

During the pilot study, we may find it necessary to stabilize the compound with protease inhibitors, or to determine non-specific drug-protein binding for each concentration so we can normalize the binding ratio. Our extensive experience with protein binding studies enables us to handle compounds with limitations of stability and/or solubility.

Screening Assays

The compounds are spiked into plasma or serum and dialyzed overnight using the RED device. Following the incubation, the recovery samples, donor sides, and receiver sides are analyzed by time-of-flight mass spectrometry using a generic method. We then calculate the binding values and percent recovery from the relative peak heights.

When compounds with low recovery are encountered, we notify the sponsor and give them the option of investigating non-specific binding and stability in plasma.

Deliverables

An Excel spreadsheet with the drug-protein binding data will be submitted immediately after completion of the experiment. If desired, a formal report complete with the Abstract, Experimental, Results, and Conclusions can be provided as well. The formal report is suitable for inclusion in regulatory submissions.

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Biomarker Analysis
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MicroConstants provides biomarker testing and analysis services to support preclinical and clinical diagnostic research of new therapeutics. We perform biomarker assay development, validation, and profiling of disease panels using multiplex, LC/MS/MS and ELISA techniques.

Multiplex Biomarker Assays (Luminex)

Using the... Show more »

MicroConstants provides biomarker testing and analysis services to support preclinical and clinical diagnostic research of new therapeutics. We perform biomarker assay development, validation, and profiling of disease panels using multiplex, LC/MS/MS and ELISA techniques.

Multiplex Biomarker Assays (Luminex)

Using the Luminex platform for biomarker assay development, validation and profiling of disease panels enables us to simultaneously interrogate up to 100 analytes in each sample. Nucleic acids or protein samples are examined to detect biomarkers that correlate with the progression of a disease or success of a therapy.

Performing multiplex biomarker analysis using the Luminex platform with xMAP technology enables us to:

  • Profile disease panels with fast reaction kinetics
  • Develop biomarker assays with a wide dynamic range and high reproducibility, specificity, and sensitivity
  • Require smaller sample sizes than single-plex biomarker assays
  • Generate more information on interrelationships between analytes within a single sample
  • Provide the high-throughput and high-content data required for simultaneous multiple lines of investigation of complex diseases and of combinatorial correlations of coexistent pathologies

LC/MS/MS Biomarker Assays

MicroConstants develops and validates highly selective bioanalytical methods for the simultaneous quantitation of multiple biomarker peptides or epitope peptides of monoclonal antibodies in serum or plasma matrices using Solid Phase Extraction (SPE) coupled with UPLC/MS/MS. The increased sensitivity of the Xevo TQ-S triple quadrupole mass spectrometer coupled with UPLC provides the specificity, accuracy and precision required for biomarker quantitation.

ELISA Biomarker Assays

MicroConstants provides ELISA biomarker assay development and validation for biomarker identification using the following formats:

  • Competitive immunoassays for peptides and small molecules such as nucleotides and eicosanoids
  • Immunometric “sandwich” ELISA format assays for large protein analytes including cytokines, cell stress proteins, and signaling pathway regulators

Each assay undergoes rigorous testing to ensure high precision and accuracy while also delivering the sensitivity and specificity required to detect biological levels of analytes in over 35 biological matrices including blood, serum, plasma, CSF, and tears. High-throughput screening using automated instrumentation is also available.

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Human Biobanking
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Long-term sample storage services include the following:

  • Sample inventory upon receipt
  • Sample accessioning into in-house database
  • Unique identification number for each sample

Storage Conditions

Long-term sample storage is available in the following conditions:

Long-term sample storage services include the following:

  • Sample inventory upon receipt
  • Sample accessioning into in-house database
  • Unique identification number for each sample

Storage Conditions

Long-term sample storage is available in the following conditions:

  • Refrigerated
  • Frozen (-20°C and -70°C)
  • Room temperature

Temperature Monitoring

MicroConstants uses GE Infrastructure Sensing LabWatch Temperature Monitoring System to ensure all refrigerators and freezers remain in range.

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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Pharmacokinetic Data Analysis / PK Modeling

MicroConstants specializes in conducting pharmacokinetic (PK) data analysis for discovery, preclinical, and clinical studies. We perform either model dependent (compartmental) or model independent (noncompartmental) analyses using validated Phoenix WinNonlin software to calculate... Show more »

Pharmacokinetic Data Analysis / PK Modeling

MicroConstants specializes in conducting pharmacokinetic (PK) data analysis for discovery, preclinical, and clinical studies. We perform either model dependent (compartmental) or model independent (noncompartmental) analyses using validated Phoenix WinNonlin software to calculate bioequivalence, drug exposure, and drug recovery data. We will also provide assessments of PK/PD relationships.

Toxicokinetic Data Analysis

For GLP toxicology studies, we perform model independent (noncompartmental) analysis to establish exposure, accumulation, and linearity of absorption.

PK Simulations

We can use existing PK data to predict the plasma concentration profile of a drug under various input conditions. This information allows you to preview the potential effect of various routes of administration, multiple dosing regimens, and variable infusion schedules and can provide valuable insight into the design of preclinical and clinical studies.

Consulting

Our scientists have decades of drug discovery and development experience and will provide you with the advice and support necessary to help advance your pharmacokinetics programs. MicroConstants can help design appropriate pharmacokinetic studies, perform pharmacokinetic calculations, and incorporate bioanalytical data into regulatory submissions.

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Analytical Method Development
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Our method development team specializes in developing and validating robust methods for the analysis of small molecules, proteins, peptides, and metabolites. Since 1998, MicroConstants has developed over 1,600 LC/MS/MS, HPLC/UV, HPLC/FL, and ELISA methods, including more than 100 non-proprietary assay methods.

We have solved... Show more »

Our method development team specializes in developing and validating robust methods for the analysis of small molecules, proteins, peptides, and metabolites. Since 1998, MicroConstants has developed over 1,600 LC/MS/MS, HPLC/UV, HPLC/FL, and ELISA methods, including more than 100 non-proprietary assay methods.

We have solved difficult analytical problems including the detection of amino acids, peptides, steroids, cephalosporins, and chiral separation of various enantiomers using liquid chromatography/tandem mass spectrometry (LC/MS/MS). Despite the analytical complexity, our scientists approach every compound with creativity, innovation, and years of scientific knowledge, allowing us to uncover solutions to complex bioanalytical challenges.

Method Development & Validation Services

MicroConstants performs method validations, method transfers, partial validations, cross-matrix validations, full GLP validations, or any combination of them required to meet your analytical needs.

The parameters evaluated during method validations are based on the validation protocol for the study. Following validation protocols enables us to accommodate our clients’ needs for the assay validation and ensure that the appropriate regulations and guidances are being followed.

All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation and performed in accordance with USFDA, OECD and MHLW Good Laboratory Practice regulations. Additionally, method validation protocols may be written to adhere to the European Medicines Agency (EMA) Guidelines on Bioanalytical Method Validation.

Techniques Available

  • LC/MS/MS (HPLC, UPLC, on-line SPE)
  • HPLC/UV
  • HPLC/FL
  • ELISA (EIA, LIA, FIA)

Non-Proprietary Assays

We have developed more than 100 non-proprietary assays for some of the most commonly tested compounds, including medications used for pain, oncology, and birth control. These methods are typically used to support studies such as drug-drug interaction, co-administration, new routes of administration, or bioequivalence studies.

Method Development Experience

The case studies below provide specific examples of ways we have helped advance our clients' drug development programs:

  • Optimizing enzymatic digestion to create a stable derivative enabled us to develop an LC/MS/MS method to measure concentrations of a key biomarker directly related to the activity of a biologic.
  • The development of a novel extraction and derivatization scheme allowed us to simultaneously determine free and covalently bound drug concentrations using a single assay.
  • The development of a non-traditional internal standard by derivatization allowed our client to maintain their rigorous timeline without resorting to an expensive synthetic effort.
  • Employing selective extraction in method development enabled the accurate determination of in vivo drug concentration in plasma samples collected during our client’s Phase I trial.
  • Increasing assay sensitivity to determine drug concentration in epithelial lining fluid (ELF) samples allowed our client’s clinical trial to proceed uninterrupted, saving them time and resources.
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Mass Spectrometry
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In vitro Disease Models
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One of the concerns of developing new pharmaceutical candidates is how the compound will interact with co-administered medications. These drug-drug interactions result in different pharmacokinetic profiles and may lead to an adverse event or loss of efficacy for either the candidate or the marketed medicine.

MicroConstants... Show more »

One of the concerns of developing new pharmaceutical candidates is how the compound will interact with co-administered medications. These drug-drug interactions result in different pharmacokinetic profiles and may lead to an adverse event or loss of efficacy for either the candidate or the marketed medicine.

MicroConstants offers a range of services to evaluate the potential for drug-drug interactions, including cytochrome P450 (CYP450) induction studies, CYP/UGT inhibition studies, and CYP/UGT reaction phenotyping. In vitro drug-drug interaction studies are performed in accordance with FDA Guidance on Drug-Drug Interaction Studies (PDF).

Cytochrome P450 (CYP450) Induction Studies

CYP induction assays assess whether the test article can increase the production of metabolizing enzymes or transporters involved in the distribution and clearance of all administered medicines. Plateable cryopreserved hepatocytes from one or more donors are used to assess the potential of a compound to induce drug metabolizing enzymes and transporters. The receptors tested include AhR, PXR, and CAR and the endpoints include mRNA and enzyme activity.

USFDA and EMA guidance requires that induction studies provide mRNA data for CYP1A2, CYP2B6, and CYP3A4 isoforms; however, we can provide relative levels of mRNA for any target of interest for a particular drug development program. For example, we have provided mRNA data for the following targets: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, P-gp (ABCB1), BCRP (ABCG2/MXR), BSEP (ABCB11/sP-gp), NTCP (SLC10A1), OSTalpha (SLC51A), OSTbeta (SLC51B), MATE-1 (SLC47A1), MRP2 (ABCC2), OATP1B1 (SLCO1B1/OATP2), OATP1B3 (SLCO1B3/OATP8), OCT1 (SLC22A1), ASBT (SLC10A2/NTCP2), and SHP (PTPN6; protein tyrosine phosphatase), and CYP7A1.

CYP/UGT Inhibition Studies

Inhibition studies are used to investigate potential drug-drug interactions and determine the ability of the test article to inhibit the clearance of other compounds.

CYP450 inhibition studies are conducted with human liver microsomes, FDA-accepted probe substrates, and control inhibitors. Both IC50 and Ki values can be determined, and the pre-incubation of the test article with microsomes and NADPH are used to assess time-dependent inhibition. Alternatively, we can use recombinant CYP450 enzymes with fluorogenic probe substrates in screening assays.

For UGT inhibition studies, recombinant UGT enzymes are used to assess the IC50 values of a test article with respect to the most common isoforms: 1A1, 1A3, 1A4, 1A6, 1A9, 2B7, and 2B15. Other isoforms can be included upon request.

CYP/UGT Reaction Phenotyping (Enzyme Mapping)

CYP/UGT reaction phenotyping, or enzyme mapping, determines the CYP or UGT enzymes that are involved in the metabolism of a compound to predict which enzymes may be critically important for the proper clearance of the test article.

Three FDA approved methods may be used, including correlation analysis, isoform-specific chemical inhibition, and/or CYP/UGT recombinant enzymes. The correlation analysis involves a bank of liver microsomes from at least 10 donors. We conduct a pilot study to determine the appropriate reaction conditions for each project. Recombinant UGT enzymes can be used to determine which isoforms are capable of metabolizing the test article.

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HPLC
High Performance Liquid Chromatography
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Drug Discovery Consulting
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Our scientists have decades of drug discovery and development experience and will provide you with the advice and support necessary to help advance your pharmacokinetics programs. MicroConstants can help design appropriate pharmacokinetic studies, perform pharmacokinetic calculations, and incorporate bioanalytical data into regulatory submissions.

Our scientists have decades of drug discovery and development experience and will provide you with the advice and support necessary to help advance your pharmacokinetics programs. MicroConstants can help design appropriate pharmacokinetic studies, perform pharmacokinetic calculations, and incorporate bioanalytical data into regulatory submissions.

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Bioanalytical Assays
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MicroConstants develops and validates highly sensitive and specific immunoassays to quantify peptide or protein therapeutics in various types of formulations and biological matrices. Our Immunology Department also assesses drug immunogenicity, evaluates anti-drug antibody (ADA) neutralization activities, and performs toxicokinetic... Show more »

MicroConstants develops and validates highly sensitive and specific immunoassays to quantify peptide or protein therapeutics in various types of formulations and biological matrices. Our Immunology Department also assesses drug immunogenicity, evaluates anti-drug antibody (ADA) neutralization activities, and performs toxicokinetic and pharmacokinetic (PK/TK) analysis of biological samples from preclinical, GLP toxicology, and clinical studies.

Immunoassay Method Development, Validation & Sample Analysis

ELISA Method Development, GLP Validation & Transfer

For novel protein therapeutics, we will design, develop, and validate custom immunoassays using the antibody of your choice, or of commercial origin. If needed, we can also assist with the generation of custom/novel antibodies against your protein therapeutic. For assays developed in non-GLP laboratories, we can transfer and validate them at MicroConstants under GLP regulations.

ELISA Kit Validation

We will qualify or validate commercially available ELISA/EIA kits for your preclinical or clinical sample analysis needs. This includes identifying the best available assay kit and evaluating it for compatibility with your peptide or protein.

Automated ELISA Validation & Sample Analysis

Using liquid handling and robotic pipetting technologies we are able to automate ELISA methods, avoiding extraction of samples for measurement. This allows us to streamline sample analysis while also providing maximum accuracy, reproducibility, and fast data turnaround times.

Stringent in house immunoassay development and validation processes ensure the highest possible ELISA performance. ELISA protocols can be validated to support preclinical and clinical studies for analysis in a wide variety of matrices.

Immunogenicity Testing

Addressing the immunogenicity against large molecule drugs has become critical in assessing their long-term safety. To detect and characterize the level of immunogenicity, we evaluate the anti-drug antibody (ADA) response of biopharmaceutical products using a multi-tiered approach including ADA prescreening, confirmatory assays, and anti-drug activity titers.

Neutralizing Antibody Assays

The most significant function of anti-drug antibodies are their ability to neutralize large molecule’s binding to targets, or inhibit their enzymatic activity. We determine the presence of neutralizing antibodies using in vitro binding assays (surrogate neutralization assays) and enzyme activity assays.

Enzymatic Activity Assays

We perform enzymatic activity assays to assess the potency of recombinant enzymes/enzyme inhibitors, monitor PD biomarkers, and measure the ADA neutralization activity against recombinant enzymes.

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Bioanalytical Analysis LC/MS/MS
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MicroConstants is one of the largest bioanalytical LC/MS/MS service providers on the West Coast of the United States, housing 15 LC/MS/MS systems and occupying 34,000 square feet of office and laboratory space in San Diego, California.

Our Bioanalytical Chemistry Department specializes in developing and validating robust... Show more »

MicroConstants is one of the largest bioanalytical LC/MS/MS service providers on the West Coast of the United States, housing 15 LC/MS/MS systems and occupying 34,000 square feet of office and laboratory space in San Diego, California.

Our Bioanalytical Chemistry Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LC/MS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and HPLC/FL. We have experience analyzing API and metabolites in more than 25 different biological matrices and can provide bioanalytical support throughout all the stages of drug development.

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Assay Development
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We have developed more than 100 non-proprietary assays for some of the most commonly tested compounds, including medications used for pain, oncology, and birth control. These methods are typically used to support studies such as drug-drug interaction, co-administration, new routes of administration, or bioequivalence studies.

We have developed more than 100 non-proprietary assays for some of the most commonly tested compounds, including medications used for pain, oncology, and birth control. These methods are typically used to support studies such as drug-drug interaction, co-administration, new routes of administration, or bioequivalence studies.

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Liquid Chromatography
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Biomolecular Interaction Analysis
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Biospecimen Management and Storage
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Biomarkers
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Drug Absorption Studies
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Cells and Tissues
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Omics
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Drug Discovery
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Metabolomics
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Biology
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Project and Process Management
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In vitro ADME/DMPK Studies
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Pharmacology & Toxicology
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Chemistry and Materials
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Imaging & Spectroscopy
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Experimental Design
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Purification Services
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Biospecimens
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Analytical Chemistry Services
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Chromatography
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Biochemistry & Molecular Biology
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Drug Discovery & Development
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In vitro Bioavailability/Bioequivalence Studies
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Bioanalysis
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Spectroscopy
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