Altogen Labs In Vivo Pharmacology Services
Altogen Labs http://altogenlabs.com provides in vivo toxicology and pharmacology services http://altogenlabs.com/biology-labora.... Toxicology studies can be focused on the acute toxicological effects after a single large dose of a substance as well as long-term studies focused on researching subchronic and chronic effects.
A subchronic toxicology study can include repeatedly administering small doses of the substance in question over a period of up to 90 days.
Chronic studies, on the other hand, can study the toxic effects of the experimental substance for months to years.
-Purpose of Toxicology Testing
Preclinical toxicology studies are required to establish the toxicological profiles of new drug candidates prior to administration to humans, and to extend the known profiles of existing drugs (e.g., new indications, new formulations, new routes of administration, etc.). Preclinical studies used for direct extrapolation to human safety should be conducted according to GLP.
The studies vary in length (e.g., acute, sub-chronic, chronic) depending on the length of dosing in the clinical trial they are supporting and the stage of development of the test article (IND, NDA, BLA, etc.).
Acute toxicology studies focus on the toxicological effects following a single large dose of the substance of interest.
Sub-chronic toxicology studies include repeated small dosages of the test substance over a period of time up to 90 days.
Chronic toxicology studies focus on the long-term effects of the test substance over periods of months to years.
-In Vivo Toxicology Service (Mouse, Rat)
Preclinical in vivo toxicology is the study of toxic effects of chemical substances based on statistical and quantitative analysis. They assess the onset, severity, and duration of toxic effects, their dose dependency and degree of reversibility or irreversibility).
At Altogen Labs, toxicology studies can include acute, sub-chronic and chronic toxicity tests via several routes of exposure (e.g., oral, intravenous, intramuscular, topical, etc.).
The Study designs are flexible and can be customized to the client-specific projects. All testing complies with applicable Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations as needed.
-The variation in time and amount of test substance in taken by the subject helps create dose response curves to determine thresholds of biological activity associated with the test substance as well as levels of toxicity.
Identification of potential toxicological side effects is very important to the advance of INDs to phase 1 clinical trial. Such side effects can have an impact on the future health of the subject, its progeny, and overall survival rate.
Potential side effects can be detrimental to the immune system, the integrity of the DNA and the functionality of vital organs.
Hence additional tests can be run to study sensitivity, irritation, mutagenic and/or carcinogenic properties, reproductive toxicity and immuno-toxicity.
-Another focal point is the route of administration of INDs. The ability of a drug to reach its target in a living system can unintentionally be deterred by immune system mechanisms, metabolic processes, and similarly natural mechanisms. Then the INDs are no longer directly targeting the desired cells but are faced with a living biological system in which their target is one of many. As a result, various drug administration routes are explored to determine toxicity and benefits.
Evaluation of drug administration routes should anticipate clinical results and optimize beneficial efficacy.
Thus the study should determine a safe and effective procedure for administration, as well as dosage for the drug to prevent any adverse effects.
-In vivo toxicology studies are also required to establish the toxicological profiles of materials that may pose a significant human health risk via environmental exposure
Implications of the above these studies can lead to phase 1 clinical trial INDs if they show promising results and minimal toxicological, carcinogenic and mutagenic effects.
Studies focusing on pharmacodynamics, pharmacokinetics and ADME processes also contribute greatly to the INDs application.
Refer the link for more details on FDA application for INDs:
http://www.fda.gov/drugs/developmenta...
-Our Services
Acute toxicity
Sub chronic toxicity
Chronic toxicity
Pharmacokinetics
In vitro permeation studies
In vivo absorption studies
Irritation and sensitization
Immunotoxicity
Reproductive toxicity
Pharmacology
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