Pharmacokinetics & Bioanalytical Capabilities
Understand your compound’s journey – from absorption to excretion.
At IIBAT, we provide high-quality pharmacokinetic (PK) and bioanalytical services that support early drug development, non-clinical safety studies, and regulatory submissions. Our goal is to help you understand how your compound behaves in a biological system—enabling evidence-based decisions in formulation, dosing, and risk assessment.
With advanced LC-MS/MS instrumentation, a team of expert analysts, and GLP-compliant operations, we deliver reliable data for ADME, bioavailability, toxicokinetics, and metabolite profiling.
🔬 Why PK & Bioanalysis Matter
Pharmacokinetic and bioanalytical studies are essential for:
- Determining systemic exposure and absorption profiles
- Interpreting toxicology study results
- Designing clinical trials
- Establishing bioequivalence between products
- Gaining regulatory approval for generics, biosimilars, and novel drugs
Whether you’re preparing for an IND, NDA, BLA, or ANDA submission, our PK and bioanalytical services provide critical insights regulators rely on.
Our pharmacokinetic and bioanalytical services provide detailed insight into the absorption, distribution, metabolism, and excretion (ADME) of compounds. These studies are vital for early drug development, toxicological interpretation, and dossier submissions for regulatory approvals in both human and veterinary medicine.
1. ADME Studies
We support:
Absorption studies: Oral vs. IV bioavailability, Cmax, Tmax, AUC
- Distribution studies: Tissue concentration profiling, plasma protein binding
- Metabolism: In vitro (liver microsomes, hepatocytes), in vivo metabolite ID
- Excretion: Mass balance studies through urine, feces, bile
✅ Conducted in rodents and non-rodents
✅ Supports early-phase drug development, formulation optimization
2. Toxicokinetics (TK) Studies
Objective: Evaluate systemic exposure at toxic doses used in non-clinical safety studies.
Deliverables:
- Dose-exposure relationships
- AUC, Cmax, half-life, clearance, and volume of distribution
- Time-dependent accumulation and saturation analysis
- Comparison between sexes and dose groups
✅ GLP-compliant reports aligned with ICH M3(R2) and S3A guidelines
✅ Crucial for correlating toxicological findings with exposure levels
3. Bioavailability & Bioequivalence (BA/BE) Studies
Objective: Determine how well a drug is absorbed and how two formulations compare.
Services include:
- Absolute bioavailability (IV vs. oral dosing)
- Relative bioavailability (comparison of two oral formulations)
- Bioequivalence assessment using statistical parameters:
- AUC0–t, AUC0–∞, Cmax, Tmax
- AUC0–t, AUC0–∞, Cmax, Tmax
✅ Supports generic drug submissions (ANDA), reformulations, and FDC development
4. Bioanalytical Method Development & Validation
Objective:
Accurately quantify drug concentrations and metabolites in biological matrices.
We offer:
- Method development for small and large molecules
- Sample matrices: plasma, serum, urine, bile, tissue, CSF
- Validations per FDA, EMA, and OECD guidance
- Techniques: LC-MS/MS, HPLC-UV, ELISA, fluorescence detection
Parameters validated:
- Specificity, linearity, accuracy, precision
- Sensitivity (LLOQ), matrix effects, recovery, stability
✅ Used in support of GLP/GMP studies and regulatory filings
5. Metabolite Profiling & Identification
Objective: Understand how your compound is metabolised and what metabolites are formed.
Capabilities:
- In vitro metabolism studies using microsomes, hepatocytes, S9 fractions
- In vivo metabolite identification in urine, plasma, bile
- Structure elucidation of metabolites using LC-MS/MS and high-resolution MS
- Mass balance studies and metabolic pathway mapping
✅ Supports safety evaluation, drug-drug interaction studies, and regulatory submissions under ICH M3(R2) and S9
Why Choose Us?
GLP-compliant, regulatory-ready outputs
Rapid method development and flexible sample volumes
Integrated with toxicology and efficacy studies for a one-stop solution
