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QUALITY MEDICATION CARE
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THERAPEUTICS
We can provide technical and analytical support for your therapeutics work. With assay development support from our scientific team, we can provide quantification and screening services for drugs and other therapeutic agents, even for those that don’t have standard commercial assays. We have experience delivering analytical studies that have been used for regulatory submissions, commercial ventures, clinical trials and academic research.
Areas of Experience:
Topical product studies – IVPT studies for skin permeation to determine the fate of drugs applied to the skin.
Drug and poisoning dosage studies – Quantification studies for drugs and metabolites in human and animal samples in biological matrices by LCMSMS and GCMS.
Metabolic Studies – Microsomal triple pack studies for metabolism of drugs and products to identify metabolite formation for regulatory approval.
Quantification of novel products – Quantification of systemic and local concentrations of target molecules
EXAMPLE PROJECTS UNDERTAKEN:
Clearance of quinidine alternative drugs in clinical trial patients after administration.
Quantification of drugs of abuse after overdose events leading to cardiac issues in patients.
Quantification of endogenous serum levels of drugs and hormone levels to determine the safety and efficacy of a novel hormone replacement therapy dosing device.
Skin and Dermatology
We have some of the most prominent experts on skin studies in Australia, who can help deliver high quality investigations for your skin products. We can perform In vitro human skin permeation test (IVPT) studies that look at skin permeation and formulation effectiveness, then partner them with our high sensitivity assays. Our services in this space have been used for product development, regulatory approvals and safety studies for pharmaceutical, cosmetic and environmental products. We have been providing this service for more than 25 years.
Areas of Experience:
Topical product studies – IVPT studies for skin permeation to determine the fate of drugs applied to the skin.
Formulation development and analysis – Comparing the efficacy of different formulations for drug and product delivery.
Safety Studies – Determination that products are delivered where intended when applied topically and what levels of systemic exposure are observed.
Portfolio:
Demonstrating non-permeability of topically applied insecticides for regulatory approval for new active compounds.
Comparison between the dosage effectiveness of two topical analgesic formulations.
Systemic exposure to tea tree oil through application of cosmetic products to the skin and safety factors resulting from application.
Comparison of transdermal delivery systems for nicotine delivery in vivo and in vitro.
Clinical Trials
We can provide technical and analytical support for your clinical trials. With our analytical experience, product testing knowledge and therapeutics experience we can support you to give you the data to make informed decisions and understand how studies have developed.
Areas of Experience:
Analysis of clinical samples to quantify drug levels in samples, such as serum, blood, biopsy.
Developing new analytical assays to support sample analysis for drugs and compounds that are not yet approved or are emerging in alternative applications.
pKPD and TKTD analysis of clinical trial data
Portfolio:
Quantification and screening of drug levels in patient serum and dialysate for polypharmacy patients under care for renal failure.
Monitoring levels of diabetic management drugs before and after interventions due to adverse events.
Clearance of quinidine alternative drugs in clinical trial patients after administration.
Environmental Management
We have experience in environmental assays and studies that can be used for environmental testing, research and screening, with researchers who have been heavily involved with.
Areas of Experience:
Pesticide screening – Investigations into contaminants in environmental, animal, food samples etc..
Environmental contaminants – Detection and quantification of products of concern in environmental samples.
Trace component detection – Identification and quantification of compounds of interest in a variety of environmental samples.
Poisoning incidents – Detection and validation of poisoning incidents in humans and animals.
Portfolio:
Confirmation of diquat poisoning after environmental exposure by urine analysis.
Screening for pesticides in a patient after a reported pesticide poisoning from an unidentified pesticide source.
Detection and quantification of polyfluoroalkyl carbons (PFAS) in patient and environmental samples.
ProducT Testing
Our product testing experience allows us to tailor our investigations to help you get your product developed, through regulation and to market. We have provided backing studies for products to go through the TGA and other international regulatory authorities.
Areas of Experience:
Safety studies investigating systemic levels of drugs, hormones, or similar in product trial samples.
Quality and stability testing for novel formulations of products.
Investigation of the efficacy of delivery systems for drugs and products.
Extended studies on your products including metabolism studies, systemic level analysis and permeability testing.
Animal studies using product to determine product effectiveness, safety or compatibility.
Portfolio:
Stability and quality testing of sunscreen formulations to determine shelf life, efficacy, degradation and safety for regulatory approval.
Comparison of transdermal delivery systems for nicotine delivery in vivo and in vitro.
Quantification of endogenous serum levels of drugs and hormone levels to determine the safety and efficacy of a
novel topical dosing device.
Metabolic studies using human, dog and rat cytochromes to determine metabolic fate of applied products to be used for new topical formulations.
Catalogue:
Diabetic Medications including metformin and the SGLT2 inhibitor family.
Beta Blockers such as propranolol, atenolol and many other widely used alternatives.
Pesticides and herbicides including paraquat, diquat, glyphosphate.
Over the counter medication such as lidocaine, loperamide, paracetamol and similar.
Steroids, hormones and other endogenous compounds including assays for estrogens and fludrocortisone
Many more available – contact us and ask if we have it in our library
Portfolio:
Stability and quality testing of sunscreen formulations to determine shelf life, efficacy, degradation and safety for regulatory approval.
Comparison of transdermal delivery systems for nicotine delivery in vivo and in vitro.
Quantification of endogenous serum levels of drugs and hormone levels to determine the safety and efficacy of a
novel topical dosing device.
Metabolic studies using human, dog and rat cytochromes to determine metabolic fate of applied products to be used for new topical formulations.