A critical component of the development process for investigational new drugs (INDs) is the establishment of clear, purposeful analytical methods which will a) facilitate product release and b) determine product stability, storage conditions, and shelf life. To ensure the safety and intended efficacy of novel pharmaceuticals, CDMOs must evaluate various quality attributes (e.g., identity, appearance, potency, purity, dissolution, microbial activity) of the drug products they manufacture. Thus, analytical testing methods need to yield data that is reliable, reproducible, and compliant with industry guidelines set forth by the FDA.
Mikart employs a phase-appropriate approach for method development and validation which leverages our experience in pharmaceutical manufacturing and release as well as our analytical technical expertise. This allows us to deliver accurate and reliable methods which can be adapted for early phase clinical through commercial products, in a manner that is both efficient and cost-effective for our customers. The following table summarizes validation requirements for method parameters, given a drug product’s clinical phase:
| Validation Parameter | Phase 1 | Phase 2 | Phase 3 |
| Specificity* | required | required | required |
| Repeatability | required | required | required |
| Linearity | required | required | required |
| Accuracy | required | required | required |
| Detection Limit (LOD)* | required | required | required |
| Quantitation Limit (LOQ)* | required | required | required |
| Solution Stability | required | required | required |
| Intermediate Precision | optional | required | required |
| Robustness | optional | optional | required |
* If applicable
Additionally, Mikart is licensed by the Drug Enforcement Agency (DEA) to handle Schedule I through V drug substances and has extensive experience in the manufacture, testing, release and packaging of various oral solid and liquid dosage forms for controlled drug products. Mikart’s methods are developed and validated to current Good Manufacturing Practice (GMP) standards and are fully compliant with all CFR and ICH guidelines. To learn more about procedures for validation of analytical methods for pharmaceutical products, download the most recent FDA Guidance Document.