When is GLP & Non-GLP Testing Required?

Good laboratory practice (GLP), an integral part of the highest standards in drug development, ensures that non-clinical animal studies are performed to the highest standards. However, it is not always necessary in toxicology studies. Most non-clinical toxicology studies require GLP regulations, including IND submissions. In certain situations or phases of non-clinical testing, investigators don't need to comply with GLP. Drug sponsors can investigate preliminary drug safety by obtaining data on drug absorption, distribution, metabolism, and elimination (ADME) properties during the early testing phase of drug discovery. This can minimize the risk of failure in preclinical studies and help sponsors decide whether the project is worth moving forward. Due to reduced regulatory scrutiny, non-GLP studies can be conducted with shorter test durations, smaller sample sizes, and faster report delivery.

Service Overview

Ace Therapeutics is a professional, comprehensive supplier of preclinical ophthalmology research solutions. With extensive expertise in ophthalmology and drug discovery, our team of experts provides customized program development services to our global clients. Our services range from supporting clients with early pilot studies and proofs-of-concept to the implementation of preclinical GLP projects.

Our scientists understand what data an ophthalmic product needs before entering clinical trials. Our research plan will be customized according to your project, which can improve your chances of success and develop effective new treatments. With our customized plan and fast and efficient implementation, we help you anticipate and respond to challenges scientifically. You can better proactively address issues earlier in the drug discovery journey, reducing project risk and being more economical.

Access Our Customized Non-GLP Ophthalmic Program Development Services

• Customized Non-GLP Ocular Toxicology Study

• Single and repeat dose-ranging study
• Acute, subchronic, and chronic local toxicology study
• Maximum tolerated dose (MTD) study

• Customized Non-GLP Ocular Pharmacokinetic Study

• Provide the data needed for clinical trials of your ophthalmic products, such as drug absorption, distribution, metabolism, and elimination data, to help determine clinical drug regimens, predict drug efficacy and toxicity, and know clinical rationality.

• Customized Non-GLP Ocular Pharmacodynamics Study

• Development of custom models
• Assessment of ophthalmic products' effectiveness

• Customized Early Test Services

• Pilot studies and proof-of-concept: Identify compounds that can be optimized, optimize the formulation of existing drugs, or optimize the delivery mode of existing drugs by our early ocular pharmacology, pharmacokinetics (PK), and tolerability studies help you ensure successful delivery to the target position.
• Formulation optimization: Provide preclinical ocular formulation optimization services for small batches of test substances, and explore the optimal drug delivery system or drug delivery method for the formulation in the model.
• Ophthalmic delivery system optimization: Develop and customize specific drug delivery methods as well as the more common drug delivery systems, including oral, intravenous, and subcutaneous delivery, based on your product characteristics.

Our Core Capabilities

• Fluorescein angiography
• Electroretinogram (ERG)
• Slit lamp exam (SLE)
• Optical coherence tomography (OCT)
• Funduscopy
• Histopathology
• IHC and histopathology
• Enzyme-linked immunosorbent assay (ELISA)
• Flow cytometry (FC)

Advantages of Services

• Individualized study design to meet the unique needs and regulatory requirements of partners.
• Experienced and state-of-the-art ophthalmology specialists.
• Provide technical advice and support throughout the research process.
• Study design based on the latest guidelines.
• Low cost.

Thanks to strong professional knowledge and an advanced technology platform, Ace Therapeutics is pleased to provide comprehensive customized non-GLP ophthalmic program development services. If you are interested in our services or need more detailed information, please feel free to contact us. Our experienced scientists are ready to help you!

• Ocular Toxicology Services
• Ocular Pharmacology Services
• Ocular Pharmacokinetic Services
• Ocular Histology and Histopathology Services
• Customized Services for Ocular Drug Delivery System Development

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• * All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

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