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Validation of Non-chromatographic Methods (NIRA, Bioanalysis and Particle Size Analysis)
Thursday, November 15
8:30 am – 11:00 am
Symposium
ACPE #073-999-07-529-L04
The pharmaceutical industry is increasingly turning to near-infrared spectrometry (NIRA) to determine the quality of raw and in-process materials, as well as final products. The validation of a near-infrared method may involve different approaches depending on how and where the analysis is being performed. Univariate and the increasingly widespread multivariate instrument calibrations require separate validation criteria used to demonstrate the applicability of the method within that calibration or training set. Similarly, method validations performed to determine the appropriate use of a method in a laboratory will be approached differently from validations used to determine at or online product quality. This session will provide perspectives and approaches for the various implementations of NIRA seen across the industry. Non-chromatographic methods in bioanalysis of drug candidates: Majority of the sample analysis in non clinical and clinical drug development uses some form of chromatography with various detection techniques. In recent times few small molecules and majority of the biotech products using variety of biochemical (PCR, RT-PCR) Radiochemical (ELISA, RIA), microbiological and Mass spec techniques not requiring elaborate sample processing prior to the analysis. Non chromatographic methods offer the advantages for rapidity and adoptability for automation. Guidelines and validation protocols are not well defined for these non-chromatographic methods unlike their chromatographic counter parts. In this talk we will present how to make these non-chromatographic methods to be selective, specific and compliant on par with the chromatographic methods acceptable for global regulatory bodies. Particle Size Analysis: Particle size distribution of API is critical in formulation, manufacturability, and bioavailability of the drug product (Solid Dosage Forms). Guidelines on particle size distribution of API and analysis are given in ICH (6QA) and USP <429> chapter on test for laser diffraction. International Conference on Harmonization Guidance on Specifications (Q6A) indicate (b) Particle size: For some new drug substances intended for use in solid or suspension drug products, particle size can have a significant effect on dissolution rates, bioavailability, and/or stability. In such instances, testing for particle size distribution should be carried out using an appropriate procedure, and acceptance criteria should be provided. It is important to address this topic and discuss the views from Formulators, API Manufacturers, QO/Regulatory personnel on Particle Size Analysis.
Moderator
Arya P. Jayatilaka, Ph.D.
Pfizer, Inc.
The Validation of Near-infrared Spectroscopic Methods
Anthony C. Moffat, Ph.D.
University of London
Validation of Particle Size Analysis Methods
Don A. Clark, Ph.D.
Pfizer, Inc.
Validation of Non-chromatographic Bioanalytical Methods
Prasad N. Tata, Ph.D.
Mallinckrodt, Inc.