Small molecule bioanalysis can be defined as the chemical analysis of compounds in biological matrices. Our company offers small molecule drug bioanalysis services to aid in preclinical and clinical research, as well as the screening and development of small molecule medications. Our knowledge and skills in peptide, oligonucleotide, and conventional small molecule, metabolite, bioanalysis. No matter how complicated your bioanalytical task is, we'll work with you to get excellent research results.
Service Overview
Our company has on average extensive experience in developing bioanalytical methods to support small molecule bioanalysis. We provide fully GLP-compliant services for method validation and sample analysis of traditional small molecules, metabolites, therapeutic proteins, biomarkers, antibodies, nucleic acids, and peptides.
We offer a variety of chromatography techniques (HPLC, UPLC, GC, and IC) and detection techniques (UV, MS, MS/MS, ELSD, FID, fluorescence, etc) to analyze different types of compounds. We can also provide other special testing methods, such as dissolution (IR, ER, MR), solvent residues, genotoxic impurities, enantiomeric separation, ion chromatography, microbiological testing, etc. We provide method development experimental designs, progress reports, method validation protocols and validation reports, and pharmaceutical analytical methods.
Our company can also provide the following services but are not limited to:
Pharmacokinetic Properties: In vitro and in vivo methods reveal bioavailability, half-life, the area under the curve, clearance, plasma protein binding, drug-drug interactions, etc.
Analysis and Detection of Biological Samples: LC/GC-MS/MS establishment and optimization
In vivo Studies
- Different animal species: rats, mice, rabbits, dogs, monkeys, piglets, etc.
- Various routes of administration: oral, subcutaneous, intramuscular, intravenous, inhalation, etc.
- Various biological substrates: plasma/serum, tissue, bile, feces, urine excretion, respiratory gas, etc.
In Vitro Studies
- Protein binding (equilibrium dialysis, ultrafiltration centrifugation, etc.)
- Metabolic stability (primary hepatocytes, liver microsomes, S9, whole blood, plasma, etc.)
Metabolite Identification
- Identification of CYP450 enzyme subtypes
- Induction and inhibition of CYP450 enzymes
- Caco-2 penetration (one-way or two-way), transport (P-gp, BCRP, OCT1), etc.
Toxic and Side Effect
Genotoxicity: AMES, chromosomal aberration, micronucleus, single cell gel electrophoresis/comet, gene mutation, etc.
In vitro toxicity: various tissue cell IC50 (MTT, LDH method), determination of liver enzyme activity, cardiotoxicity hERG
In vivo toxicity: single DRF, multiple DRF, with toxicity generation, etc.
Prescription screening: allergic reaction, hemolysis, blood vessel and muscle irritation, pyrogen inspection, etc.
Drug efficacy evaluation
- In vitro validation: molecular, cellular, organ level (IC50, EC50, ELISA, WB, IHC).
- In vivo verification: arthritis, anti-tumor, antipyretic, analgesic, anti-inflammatory, learning and memory, etc.
Research Capabilities
As a drug moves through the drug development process, various preclinical and clinical studies are conducted in which the drug is analyzed in a biological matrix, usually serum or plasma. Common small molecule bioanalysis studies include pharmacokinetic (PK) studies, pharmacodynamic studies, and biomarker determination.
Our small-molecule bioanalytical capabilities include:
- Method Development, Transfer and Validation
- Sample Analysis
- Nonclinical Toxicokinetic/Pharmacokinetic Screening
- Clinical PK/Bioavailability Studies
- Bioequivalence Studies
- Therapeutic Drug Monitoring Studies
- Drug interaction studies
- Protein Binding Studies
- Organizational Analysis
Our expertise also extends to projects combining small and large-molecule bioanalytical activities, such as proteins, antibodies, antibody-drug conjugates, and small molecules.
Overall Solutions
| Project Name | Small Molecule Drug Bioanalysis Service |
| Service Details | - Early DMPK/ADME screening in vivo and in vitro
- Preclinical GLP drug alternative toxicology experiments
- Generic drug bioequivalence testing
- Sample analysis of global clinical trials
- Determine drug concentrations in biological matrices by developing, transferring, and optimizing LC-MS/MS methods
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| Deliverables | Within agreed time, we will provide the summary to experiment data and conclusions, as well as a final experiment report. |
| Cycle | Decide according to your needs. |
If you want to know more about service prices or technical details, please feel free to contact us.
It should be noted that our service is only used for research, not for clinical use.
