Adequacy and verifiability of pharmaceutical mixtures and dose units by variographic analysis (Theory of Sampling) – A call for a regulatory paradigm shift

Author:

Esbensen Kim H.,Román-Ospino Andrés D.,Sanchez Adriluz,Romañach Rodolfo J.ORCID

Funder

International Society for Pharmaceutical Engineering (ISPE)

National Science Foundation Engineering Research Center

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference66 articles.

1. 1 – Powder sampling;Allen,2003

2. Cohesive, multicomponent, dense powder flow characterization by NIR;Benedetti;Int. J. Pharm.,2007

3. Current events in blend and content uniformity;Bergum;Pharm. Eng.,2014

4. Assessment of blend and content uniformity. technical discussion of sampling plans and application of ASTM E2709/E2810;Bergum;J. Pharm. Innov.,2015

5. The compliance and science of blend uniformity analysis;Berman;PDA J. Pharm. Sci. Technol.,2001

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