FACTSHEET Safety Assessment

FACTSHEET
Safety Assessment
Aptuit is focused on streamlining and supporting the drug
development process for biotechnology and pharmaceutical
innovators worldwide by providing a comprehensive suite of drug
discovery and development services and competencies. Aptuit can
assist in designing development programs that compress timelines,
maintain quality and reduce the costs of commercialization.
Our unique ‘First in Man-enabling’ drug development program is
based on ICH Guidelines, and includes the mandatory core battery
of toxicology and safety pharmacology evaluations, providing the
perfect solution in reaching early candidate selection decisions.
Toxicology and Pathology Core Capabilities
• Rodent, rabbit, dog and primate facilities
• Custom designed investigative and Regulatory GLP core
studies according to current international guidelines
• GLP studies for Gene Therapy Medicinal
Product and Biodistribution studies
• Standard routes of administration (e.g. intravenous, oral, and
subcutaneous routes) and special routes of administration
(e.g. intranasal, intratracheal and intratechal)
Safety Pharmacology Core Capabilities
•C
entral Nervous System: Modified Irwin test or functional
observation battery in mouse, rat and dog. Pro-convulsant
tests such as native tissue electrophysiology, in vivo studies of
compound-inducing convulsions, potentiation of PTZ-induced
convulsions, MEST Test and video-telemetry EEG in rat
•A
buse Liability testing: consulting on abuse liability
strategy, 8-factors analysis, regulatory abuse liability
package (self administration, drug discrimination, physical
dependence/withdrawal, locomotor activity)
•C
ardiovascular System: in conscious (telemetry) and anaesthetised
rodents (mouse, rat and Guinea pig), in conscious (telemetry) dogs
and non human primates; cardiac safety in vitro
panel including hERG, hNav1.5, hCav 1.2 in automated
electrophysiology platforms and in manual patch clamp; in vitro
assessment of selectivity and liability on GPCRs and ion channels
(functional assay), enzymes and transporters (binding assay)
•C
ardiovascular and Central Nervous System: combined model
in dog
• Respiratory System: Whole body plethysmography in rat
or measurements of hemoglobin oxygen saturation
• Biomarkers identification, analytical validation and qualification
by means of standard and special clinical pathology
•G
astro Intestinal Tract: intestinal transit time by charcoal meal,
gastric emptying by non-invasive bioluminescence imaging
• TEM (Transmission Electron Microscopy) and ESEM
(Environmental Scanning Electron Microscopy)
• I nclusion of Safety Pharmacology endpoints into Toxicological
studies: CNS and respiratory assessment in rat, cardiovascular
(6 leads ECG) by using external telemetry in dog
•C
omplementary core capabilities include:
Bioanalytical, Pharmacokinetics and Drug Metabolism
services as well as Immunoassays, Immunogenicity
testing and Immunotoxicology assays
Genetic Toxicology Core Capabilities
• Ames test: standard plate incorporation and pre-incubation assays
• Chromosome aberration test: in vitro Human Lymphocytes
(HPLA) assay
- In vitro and in vivo micronucleus assay
• In vitro and in vivo Comet assay
APT/FACT/VERONA26/SAFETY/01/14/V001
FACTSHEET
Safety Assessment
Our dedicated expert team offers the highest standard of service
Aptuit’s experienced scientists have proven expertise in integrated
preclinical development for small and large molecules as well as
viral vectors and Gene Therapy Medicinal Products. They have
tailored studies and programs based on specific client needs,
maintaining an interdisciplinary attitude and taking a team
approach. Our scientists have been involved in a multitude of
multidisciplinary “problem solving” studies. Working within a
strong regulatory environment, Aptuit scientific teams provide
the assurance of client-centered project management; consistent
lead times; close working relationships with customers’ Support
Services; and, GLP Compliance independent monitoring.
It is our uncommon expertise that allows Aptuit to identify the
Uncommon expertise. Exceptional results.
For information about Aptuit’s services, please contact us:
in Europe: +39 045 821 9333
in the US: 855-506-6360
email us at: [email protected]
www.aptuit.com
Aptuit provides early to mid-phase drug development solutions by
applying scientific excellence, outstanding service and a team of some
of the foremost scientific professionals in the industry. These drug
discovery and development professionals offer proven experience
unexpected, mitigating risks and maximizing promising possibilities,
ensuring exceptional results through an open, transparent climate of
trust that our clients can count on.
Aptuit’s comprehensive drug development services include:
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•
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Drug Design & Discovery
Preclinical Biosciences
API Development & Manufacture
Solid State Chemistry
Pharmaceutical Sciences
• A
ptuit INDiGO® - fast track
to IND program
• Integrated Drug Discovery
& Development
in key therapeutic areas. They share a legacy of success, having
advanced a large number of molecules efficiently, expeditiously and
economically, from early discovery through clinical development with
low attrition rates.
APT/FACT/VERONA26/SAFETY/01/14/V001