Services

"Pleroo Research is your extended team beyond traditional borders of scientific research"

For discovery or Pre-IND

  • Simulation of plasma and tissue profiles using physicochemical and ADME data in human or pre-clinical species.

  • PKPD modelling and simulation of human efficacy concentrations

  • Comparison of various lead compounds using their PBPK based human simulation profiles allowing selection of clinical candidate.

  • Comparison with existing SOC or drugs with available clinical or experimental data to identity strategic advantages in safety, dosing regimen, interaction potential or cost of development.

  • Selection of appropriate biopharmaceutical properties to optimize formulation using PBPK based absorption modeling.

  • Support evaluation of new hypothesis or re-purposing strategies.

For Clinical development

  • Selection of doses and dosing regimen for clinical trials based on PBPK simulations and regulatory toxicology findings.

  • Population based simulations to assess the variability across a range of population based physiological characteristics (polymorphism, renal clearance etc.)

  • Simulations in special populations (renal and hepatic impairment. Pediatric)

The synergy of cross functional expertise

Do you have a research problem that requires a cross functional review or a specialized study design?

Pleroo Research can bring in critical review from a cross functional perspective to your research problem and present you with optimum experimental designs, identify clinical differentiation or enable quick and informed decision making in your research

Our experience in pre-clinical discovery and clinical development provides you an end to end perspective of research from conception to its clinical validation

"An integrated approach connecting physicochemical, in-vitro, ADMET properties and disease model information in an envelope of mathematical modeling and simulation with a clear emphasis on successful clinical development"

Pleroo Research can be your partner to complete your pre-clinical package or design development plans ensuring synergy with chemistry manufacturing and control, biopharmaceutical assessments, drug safety evaluation and clinical strategy.

Mechanistic PBPK Model based simulations: A predictive future of smart decisions

Our strong expertise in Physiological pharmacokinetic modelling (PBPK) provides you a wide range of possibilities to speed up your research by making informed decisions and or creating better clinical designs. These solutions provide significant cost advantages as well as allowing early regulatory acceptance of your research. Regulatory agencies already acknowledge PBPK-based mechanistic model driven assessments as a valid methods for crucial decisions in areas like dose selection, evaluation of interaction potential with deciding on the optimum number of studies or study waivers, as well as studies in special populations etc.

Being mechanistic and modular in design, PBPK models are flexible and can be enhanced as more information becomes available.

This opens up a spectrum of possibilities for optimisation and minimising uncertainity.

Evaluate Drug Interaction potential

Pharmacokinetic drug-drug interactions can cause clinically relevant changes in magnitude of blood and tissue concentration

of the investigational drug, its metabolites. or a co-administered drug . This may alter the safety and efficacy profile, regardless of whether they have a wide or narrow therapeutic index and may result in serious adverse events.

Drug-drug interaction can differ among individuals based on genetic variation (polymorphism) as well as in special populations (organ impairment, pediatric or geriatric).

Derive from a series of carefully planned experimental studies on in-vitro metabolism, enzyme inhibition and transporter assays, the early indications of the potential for drug interaction utilizing various static or mechanistic models , finally evaluating critical areas with PBPK based simulation.

"Utilize the vital information for optimal clinical trial designs or in support of study waiver"

Drug Development

Pleroo Research can bring in critical due diligence to your pre-clinical or IND package. Based on a "early success-quick kill" approach, we assist you in identifying and mitigating hurdles for development.

We can review information in therapeutic domains of cancer, diabetes, immunology, wound healing, allergy and CNS from PK-PD, clinical pharmacology and safety perspectives and bring in comparative information with existing therapies or simulation exercises, identifying key differntiation of the new candidate or prepare experimental designs to prove the hypothesis.

With our team of experts and partnering groups, we create elaborate clinical development plans in areas of diabetes, cancer and inflammation and help progressing your clinical programs.

Advanced Pharmacometrics, Population approaches

For a clinical program it is vital to understand the impact of population variability on the data . Along with appropriate bio-marker information, a clear understanding of the data is vital for further progression of the trial in meeting its objectives and an effective management of resources. We bring our modelling and statistical expertise with this objective in mind. Our expertise covers

Population based analysis of clinical data

Novel statistical optimisation approaches, including

dosage regimen optimization using disease models,

population PK/PD/Clinical trial end point,

emphasizing on both continuous but also categorical, count and time to event responses.

Remote execution or report your study

Pleroo Research can be a third party reviewer of pre-clinical and IND directed experiments conducted through third party organisations. W

Pleroo Research can also generate concise summaries or reports from pre-clinical or clinical phase I/II studies helping your regulatory submissions

Biopharmaceutical assessments, Bioanalytical audits and formulation development

Understanding your special needs, Pleroo Research can bring in its technical expertise in auditing bioanalytical studies ensuring their safe conduct for a variety of studies including invivo PK, toxicokinetics as well as clinical pharmacokinetic studies.

Custom experimental design and oversight

We provide custom experimental designs as well as oversight of major in-vitro ADME and PK-PD studies that address drug development challenges for research groups that require support in this area.

These studies are meant to support areas like drug safety, physicochemical characterisation, early formulation evaluations as well as studies supporting PBPK models.

"Our oversight covers experimental stages of in-vitro ADME, invivo PK, PK-PD as well as bioanalysis, providing a comprehensive support"

    • Characterisation of metabolic pathways of clearance and fraction metabolised

    • Enzyme kinetic parametes from metabolism and transporter assays

    • Mechanism based inhibition of CYP enzymes

    • Dissolution studies and invitro-Invivo correlation

    • PK-PD studies in animal models