Method Development and Validation
Our dedicated method development team has developed hundreds of methods during the past decade. These methods cover areas from API, OTC, pharmaceuticals and bioassays, to foods and nutraceuticals. Our unique capability in method development is our ability to produce a reliable and FDA recognized method in a relatively short period of a few weeks.
Product Stability and Product Release
Timely and accurate determination of identity, strength, quality, purity and potency are crucial to a successful product launch and delivery. We have extensive experience in analyzing carious OTC drugs and prescription medicines according to USP monographs or validated methods and protocols. AAC Labs has also completed many successful stability projects on diverse products types for a diversified customer base. Our services include product physical stability monitoring, stability indicating, active ingredient testing, and degradation monitoring and microbial analysis.
Counterfeit Products
AAC Labs has the experience and capability to provide services related to investigation and characterization of counterfeit products for API, therapeutics and other ingredients using a combination of HPLC, GC, LC/MS, GC/MS, FTIR, NMR and other tools. Our investigation is comprehensive and will meet or exceed our customer’s requirements.
Metabolism and Pharmacokinetics
Our services focus on the early stage of therapeutic candidate research and studies, including nonclinical toxicokinetics (TK), Pharmacokinetic (PK), Bioavailability, Bioequivalence, Toxicology and Drug-Drug Interaction.
Bioassays and Biology
A number of methods have been developed in AAC Labs for screening anticancer compounds using in-vivo & in-vitro bioassay systems. These techniques allow us to provide high throughput screening on Ornithine Decarboxylase Assay (ODC), Quinone Reductase Assay (NADP(H):Quinone Oxidoreductase), Quinone Reductase (QR), Glutathion S-Transferase, (GST), Cyclooxygenase (COX), General Toxicity, Immunotoxicity, and Skin Penetration.
Pre-clinical Studies
AAC Labs has the capacity and experience to perform pre-clinical and early clinical phase studies. Our capacity is extended through the collaboration with several laboratories at the University of Illinois, local hospitals at Champaign Illinois, and hospital and animal facilities in China. The studies may include:
- Cytotoxicity
- General Safety
- Metabolic Stability
- Immonotoxicology
- Bioavailability
- Preclinical Drug Efficacy