Discovery & Pre-Clinical DMPK

Aryastha provides a comprehensive range of services encompassing in vitro ADME, toxicity (in vitro ADMET), and in vivo pharmacokinetics (PK), offering rapid evaluations of test articles DMPK properties and toxicity. Our team specializes in crafting robust DMPK packages tailored for submissions to regulatory agencies like FDA, MHRA and GLP.

In vitro ADMET

Our team performs efficient screening assays covering the entire in vitro ADMET spectrum, including solubility, drug absorption and transport, metabolic stability, drug-drug interactions, and in vitro toxicity.

Physiochemical Properties

Drug Absorption and Transport

Drug - Drug Interaction

Metabolic Stability and Metabolite(s) Identification (met-ID)

In Vitro Toxicity

In vitro PK

Aryastha offers PK, toxicokinetics (TK), and formulation analysis services to support drug discovery and preclinical development. All in-life work of PK/TK studies is conducted in AAALAC accredited animal facilities and follows CPCSEA (equivalent to IACUC) approved study protocols.

PK/PD

PK/PD studies play a vital role in confirming the exposure of the test article in systemic circulation and tissues, particularly target organs. These studies also facilitate understanding the correlation between test article exposure and its pharmacodynamic (PD) effect, utilizing healthy and diseased animal models.
The quantification of biomarkers is expertly conducted by our In vitro biology and ex vivo pharmacology teams, encompassing the assessment of

Regulatory DMPK

Aryastha offers comprehensive IND filing DMPK packages meticulously designed to meet the regulatory requirements set forth by FDA, OECD, Indian GLP and MHRA. Our In vitro ADME filing package studies encompass regulatory considerations such as

Our in vitro PK filing package studies encompass

In Vitro Pharmacology

Our in vitro pharmacology team delivers comprehensive in vitro and ex vitro pharmacology services across key therapeutic domains, including oncology/immuno-oncology, metabolic disorders, and inflammatory diseases.

Animal Disease Models

Our in vivo pharmacology team possesses expertise in establishing and validating disease models for efficacy screening and conducting in vivo pharmacology profiling, PK/PD, and MOA studies. Complemented by our internal PK/Bioanalytical, ex vivo pharmacology, and in vitro biology teams.
  • Extensive cancer cell lines and tumor bank

  • CDX models and PDX models with access to human tumor samples through a local hospitals¬†

  • Syngeneic models with immune profiles, SOC data, and orthotopic imaging models encompassing hundreds of human and murine cancer cell lines

  • Metabolic models, obesity, diabetes, NAFLD & NASH

  • Cardiovascular diseases (MCAO, SHR, cardiac ischemia/reperfusion, hyperlipidemia)

  • Organ damage diseases models (CKD)

  • Respiratory disease models (lung inflammation and fibrosis)

  • Acute and chronic pain models

  • Immune disease models and non-immune inflammatory models

  • Arthritis, visceral pain, surgery pain, neuropathic pain models, and PD/PK models

Ex vivo Pharmacology & Biomarkers

Ex vitro analysis confirms the In vitro effects of test articles and establishes the correlation between efficacy, target engagement and biomarkers. All samples utilized in ex vitro analysis are derived from animals involved in the study, encompassing blood, plasma, cerebrospinal fluid (CSF), various body fluids, tissue extractions, urine, and feces.

PK/PD

PK/PD studies play a pivotal role in validating the exposure of the test article and biomarker levels within the systemic circulation and tissues, with a particular focus on target organs.

This aids in comprehending the correlation between the test article’s exposure and its pharmacodynamic (PD) effect, utilizing both healthy and diseased animal models. These studies encompass various aspects,

Aryastha's accelerated
late-stage lead optimization

Aryastha’s accelerated late-stage lead optimization service delivers crucial data to facilitate rapid and informed decisions in selecting and advancing the most suitable lead candidate(s) before embarking on IND-enabling toxicology studies. This efficient solution ensures the provision of essential data within a matter of weeks. Our services encompass the following

In vitro Tissue Distribution

Comparative target-distribution insights across a range of closely related compounds. This helps confirm whether the test compound(s) effectively reach the intended tissues or potentially accumulate in vulnerable tissues.

In vitro Metabolism

Contact Us

India

Aryastha Life Sciences Private Limited, ARx,
Synergy Square II, Genome Valley, Shameerpet, Hyderabad,
500078, India

+91 91547 82433

USA

Aryastha Life Sciences, Inc.
One Broadway, 14th Floor
Cambridge, MA 02142