Food and Drug Services
Our Food and Drug Services consists of a wide range of bioanalyses from residue detection to drug discovery. Whether a client is testing food products for potential contamination or evaluating a new molecular entity for all phases of drug development, CDI can provide the analytical support to provide defensible data of known quality. Offering both non-GLP and GLP compliance procedures, CDI will work with the client to ensure data quality and integrity from the preliminary phases through the duration of a defined study plan. In the event that your drug is a "controlled substance," CDI maintains a Controlled Substance Registration for all CSA Schedule 1-5 narcotics. Please contact CDI prior to sending any materials to determine if a DEA Form-222 will also be required along with your submittal.
Food Analysis
Drug Analysis
Pharmacokinetic Study [RF-PHR-PKS]
Pharmacokinetic (PK) studies characterize a drug's exposure over time and ensure that a drug can reach its target organ at a sufficient concentration to have a beneficial effect. CDI will work with the client to develop determinative assays to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a drug. PK studies are performed from the early phase of drug discovery through clinical trials and involve a variety of complex matrices. CDI will help choose the right analytical method (see Analytical Services) for document submittal and compliance (see Consulting Services).
To characterize a drug's quantitative effect on a physiological target, CDI offers a wide range of pharmacodynamic (PD) assays to evaluate drug-receptor binding (kd) and dose-response (DR) relationships. In addition, the graded dose-response relationships, i.e. potency [EC50] and efficacy [Emax], can be determined with a well designed study (see Physiological Services). In summary, these assays can be used to establish the appropriate dose range and bioequivalence of the client's drug.
Pharmacodynamic Study [RF-PHR-PDS]
Toxicokinetic Study [RF-PHR-TKS]
Toxicokinetic (TK) studies are used to characterize the adverse effects and the therapeutic index (TI) of a drug. To evaluate a drug’s toxic exposures for both acute and chronic toxicity reporting, CDI can help design a toxicokinetic study with the appropriate analytical approach to complement the Pharmacokinetic Study. CDI will work with the client to establish the maximum tolerated dose (MTD) and perform a dose range finding (DRF) study prior to repeated dose toxicity studies.
The bioavailability of a drug can be determined by the PK studies (Pharmacokinetic Study) to assess three key features of the drug or test article: maximum concentration of drug in the systemic circulation (Cmax), time to reach concentration (Tmax), and the time-drug concentration area under the curve (AUC). With the proper design and analytical applications, CDI can provide the support needed to determine the bioavailability and potential bioequivalence of a drug.
Bioavailability Study [RF-PHR-BAS]
Controlled Substance Analysis
