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Drug Efficacy in Preclinical Studies

Models used for studying diseases must exhibit pathological similarities closely resembling the conditions observed in humans. Experimental animal models are therefore useful for a better understanding of disease mechanisms and for evaluating the therapeutic efficacy of new and emerging drugs.

  • Validated models for a variety of therapeutic areas, including oncology, CNS, cardiovascular and hemostasis, respiratory, and renal and gastrointestinal disorders.
  • Expertise in a wide range of efficacy assays and methodologies.
  • A dedicated team of scientists who work closely with you at all stages of the drug discovery and development process to select the best approach for your study.

We are committed to providing high-quality data and reports that help you make informed decisions about the development of your drugs.

Biotrial-preclinical-Drug-Safety

Our dedicated team works closely with you through all stages of the drug discovery and development process to select the best approach for your efficacy study.

Oncology

Cancer is a vast group of diseases that can manifest in virtually any organ or tissue within the body and which has the potential to metastasize to other regions. It is the second most prevalent cause of mortality worldwide, driving significant research efforts and pioneering innovative oncology therapeutics.

Biotrial is a global CRO with extensive experience in both in vitro assays and in vivo models for evaluating the efficacy of new oncology drugs. 

We work closely with biotech and pharmaceutical sponsors to design and execute the most appropriate preclinical oncology efficacy studies for their specific needs. Our goal is to help our sponsors develop safe and effective new oncology drugs that improve the lives of patients around the world.

Cancer Cells Vis
Biotrial Nonclinical Drug Efficacy Cns

CNS

Biotrial provides a large range of simple and complex models for CNS efficacy studies and in setting up new models according to specific scientific requirements and project objectives.

We offer validation data & scientific guarantee for all of our CNS efficacy models. And, as a full-service translational CRO, we can help you bridge the gap between preclinical and Phase I-IV clinical trials.

  • Validation Data & Scientific Guarantee
  • Translational service CRO
  • Complementary techniques

With experienced and dedicated neurosciences experts, Biotrial’s CNS efficacy includes validated models for the following:

  • Psychiatry: Anxiety, Depression, Panic Disorder
  • Schizophrenia: Positive, Negative Symptoms & Cognitive Dysfunction
  • Neurological Disorders: Alzheimer’s Disease, Parkinson’s Disease
  • Cognition
  • EEG

Cardiovascular & Hemostasis

Cardiovascular diseases are disorders of the heart and blood vessels and are still the leading cause of death globally. Extensive research in the field always leads to new and innovative solutions to be evaluated.

For decades we have conducted cardiac and hemodynamic studies in rodents and large animals. We propose cardiovascular pathophysiological models of arrhythmias, heart failure, and thrombosis, and possess a wealth of experience in performing cardiovascular telemetry studies across all species.

We offer a comprehensive range of preclinical cardiovascular efficacy testing services, including:

  • Cardiac safety pharmacology studies to assess the potential cardiotoxicity of new drugs.
  • Cardiovascular pathophysiology models to study the effects of drugs on specific cardiovascular diseases, such as arrhythmias, heart failure, and thrombosis.
  • Cardiovascular telemetry studies to monitor the cardiovascular effects of drugs in conscious animals.
Red Blood Cells Flowing Through The Blood Stream
Biotrial Nonclinical Follow Up Cardiovascular

Respiratory

Biotrial Nonclinical Drug Efficacy Respiratory

Respiratory diseases affect the airways and other structures of the lungs. At Biotrial our preclinical unit strives to Evaluate the safety and efficacy of new respiratory disease drugs and therapies and study the disease process in more detail. We are also equipped with whole-body Plethysmography and have validated rodent models for the evaluation of drugs intended to treat respiratory pathologies, including:

  • Lung Edema
  • Airways Inflammation
  • COPD

We are also equipped with whole-body Plethysmography for the evaluation of Respiratory Function in conscious rodents

Renal & Gastrointestinal 

The kidneys filter waste and excess fluids from the blood, which is then excreted in the urine. Kidney failure describes the gradual loss of kidney function that may lead to high levels of fluid, electrolytes, and waste in the body.

Gastrointestinal (GI) diseases affect the GI tract from the mouth to the anus. Many factors can upset the GI tract, leading to various structural and/or functional pathologies and our research helps us to understand the causes and mechanisms of diseases affecting these organ systems, and to help sponsors develop new and improved human treatments.

Biotrial is a preferred partner for Biotech and Pharmaceutical companies, particularly experienced in preclinical renal and gastrointestinal efficacy studies and experience in performing a variety of renal and GI function tests. We offer a variety of renal and GI pathophysiological models, including:

Biotrial Nonclinical Follow Up Respiratory
Human Digestive System Anatomy

GI Disease Models

  • Inflammatory bowel disease (IBD)
  • Perianal Fistula

Gastrointestinal  Function

  • GI motility
  • Gastric emptying

Our Preclinical Team

Biotrial’s preclinical team has extensive experience and expertise in the efficacy assessment of new drugs. The team is composed of highly qualified scientists with a deep understanding of the preclinical efficacy testing process. Our experts are committed to providing high-quality, comprehensive, and timely efficacy assessment services to the sponsors. Our dedicated team works closely with you through all stages of the drug discovery and development process to select the best approach for your efficacy study.

Biotrial-preclinical-team

Resources

Acutely blocking NMDA receptors in rats reproduces behavioral and electrophysiological features of schizophrenia
Electrophysiological profiling of escitalopram in rodents and human healthy subjects
Detection and pharmacological modulation of sleep spindles in rat
Acutely blocking NMDA receptors in rats reproduces behavioral and electrophysiological features of schizophrenia: a robust and translational tool to assess antipsychotics and investigational drugs indicated for the treatment of schizophrenia

ABSTRACT: The therapeutic management of Schizophrenia (SZ) has not
significantly improved since the first commercialization of atypical
antipsychotics. Mostly targeting positive symptoms of SZ, these drugs
do not treat other aspects of the disease such as social dysfunction
and do not sufficiently modify SZ underlying neurobiology. The lack of
new innovative therapies for SZ has raised the question of the
robustness and translatability of preclinical methods used during
drug development. Here, we highlight a robust and translational
model aiming at evaluating drugs indicated for the treatment of SZ.
SZ being mainly mediated by N-methyl-D-aspartate receptor (NMDAr)
hypofunction, this model relies on blocking NMDAr with MK-801 in
the rat. Importantly, this model includes both behavioral (locomotor
activity (LMA) evaluation to assess psychotic-like behavior and social
interaction analysis) and EEG readouts (gamma-band auditory steadystate
response (ASSR) and quantitative EEG (qEEG)) to align with
methods used in patients. This preclinical method thereby allows
focusing on both clinical manifestations (positive symptoms and social
dysfunction) and NMDAr-hypofunction-mediated excitationinhibition
(E/I) imbalance, a key pillar of SZ for which the gammaband
ASSR is seen as a translational EEG biomarker. To further evaluate
this approach, the atypical antipsychotics clozapine and aripiprazole
were evaluated on parameters influenced by MK-801 administration.

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Electrophysiological profiling of escitalopram in rodents and human healthy subjects

Major depressive disorder (MDD) is a severe and common psychiatric disorder and although it primarily involves mood disturbances, patients usually present alterations in cognitive function.
Cognitive performance is assessed through the use of behavioural tasks but this does not allow for the establishment of a pharmacodynamic marker of underlying brain activity. Identifying
neurophysiological markers with a correlation to cognitive performance could increase the clinical utility of pharmacological compounds. This study was aimed at exploring neurophysiological
pharmacodynamic markers of cognitive performance for escitalopram, a selective serotonin reuptake inhibitor (SSRI). SSRIs have been the leading class of drugs for the treatment of depression
and anxiety for several decades and have been associated with a number of sensitive peripheral and central biomarkers. Quantitative electroencephalography (qEEG) and auditory steady-state
responses (ASSRs; electrophysiological responses entrained to the frequency and phase of a rapid auditory stimuli) were investigated in human healthy subjects and Wistar rats following
treatment with escitalopram.

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Detection and pharmacological modulation of sleep spindles in rat: a tool for safety/efficacy pharmacology using EEG telemetry recording in the conscious rat

Successful CNS drug development relies on using quantitative & predictive preclinical methods to better assess efficacy & safety. Sleep spindles (SPI) are EEG hallmark of mammals’ NREM sleep involved in cognition and memory that depend on CaV3.3 Ca2+ channels of the thalamic reticular nucleus. SPI are reduced in a number of pathologies including Schizophrenia and Alzheimer’s disease. They might therefore provide valuable & translational information regarding target engagement, efficacy and safety.

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