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GLP and Non-GLP Bioanalysis

GLP and Non-GLP Bioanalysis

Bioanalysis of small molecules, therapeutic peptides, biomarkers and complex molecules with high sensitivity and accuracy.

Aurigene offers GLP and Non-GLP bioanalysis services for small molecules, peptides, biomarkers and complex molecules. Our Bioanalytical labs are well-equipped with high-end LC-MS/MS instruments, HPLCs or UPLCs with UV, PDA and fluorescence detectors. We have completed more than 200 GLP studies. We perform sample analysis of GLP PK or TK or TD studies. We do method validation as per regulatory requirement and ensure data quality and compliance.

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Bioanalysis

  • In vitro DMPK assays- generic gradient method
  • In vivo PK, PK or PD and TK
  • GLP compliant, state-of-the-art bio analytical lab to support
  • Bio analytical method validation
  • Pharmacokinetics and tissue distribution studies
  • Toxicokinetic studies

Analysis and Deliverables

  • Bioanalysis: LC-MS/MS
  • Time vs concentration
  • PK Parameters

Why Aurigene Pharmaceutical Services?

Delivered 200+ GLP studies

Compound management and data automation

Quality and Accuracy

Regulatory submissions to US FDA, EMA, DGCI

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Frequently asked questions

What is pharmaceutical development?

Pharmaceutical development identifies and evaluates processes required to convert an NCE/drug substance into a drug product to deliver for its intended performance/purpose consistently. The pharmaceutical development process begins by measuring drug substance properties, identifying critical attributes of the drug product, checking absorption and stability profile of the drug and the most appropriate route of administration (e.g. oral, parenteral or topical).

Why is pharmaceutical development important at early drug development stage?

Pharmaceutical development evaluation already at the early drug development stage is essential for selecting the right NCE and formulation to reduce the attrition rate in the late-stage development. These activities streamline efficacy/toxicology evaluations, allowing pharmacologically effective and developable molecules to reach the clinic and eventually patients.

What are the advantages of integrated early-stage drug development?

The integration and close collaboration of preclinical and clinical development teams accelerate the FIH product development process by utilizing already available pre-formulation and bioavailability information and experience gained during preclinical formulation development. It also helps identify obstacles and apply the right formulation strategies early in the drug development process to avoid costly late-stage failures, significantly saving time and costs.

What is bioavailability?

The rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the biological system site.

What factors affect bioavailability?

The movement of the drug in the biological system is influenced by many factors such as routes of administration, physicochemical drug properties, physiological factors (e.g. gastrointestinal pH, gastric emptying, small intestinal transit time, bile salt, absorption mechanism, food, metabolism), manufacturing technique, dosage form, and excipients. Understanding the interrelationship of these factors leads to biopharmaceutical and science-based drug product developments.

Why is the oral bioavailability of drugs less than 100%?

Incomplete oral absorption could be due to poor solubility, poor intestinal permeability, or presystemic metabolism. Incomplete oral bioavailability can often be surmounted through formulation efforts.

How do you increase oral bioavailability?

We can enhance the oral bioavailability through formulation efforts using solubilizers, pH adjustment, cosolvents, complexing agents, permeation enhancers, and enabling technologies (solid dispersion, particle size reduction and lipid-based drug delivery systems).

br>By identifying potential limiting steps for oral absorption of a compound (including dissolution, solubility, permeability, and limited metabolism process), understanding the physicochemical properties of a compound, recognizing physiological processes affecting drug absorption, along with awareness of a drug's BCS and DCS characteristics, pharmaceutical scientist can better predict formulation approaches that can maximize the drug’s bioavailability.

Why is formulation development required at the preclinical drug development stage?

Formulations play a crucial role in assessing the biological properties of a molecule during drug discovery. Maximizing exposure is the primary objective of early animal experimentation to avoid discarding developable compounds with the desired pharmacologic properties.

Diversity in the physiology between various animal species, routes of administration, limited compound amount, and limitations posed by specific pharmacological models make formulation development much more challenging. Consistency in the exposure is also a key aspect as significant variations are observed in early NCE batches.

Additionally, preclinical tox (GLP) studies at early development, require NCE formulations that are simple, robust, provide ease of preparation, convenient to deliver to animals with minimal ancillary effects of vehicle and provide provision of high and dose-related systemic exposures in animals relative to anticipated human exposures to facilitate determination of tox profiles.

The selection and development of effective formulation and drug delivery strategies are essential to achieve this.

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