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ICH: Strengths, Weaknesses, and Future Tasks

Sebastian Specht1, Ingrid Klingmann2

  • 11 Pharmaceutical Division, F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Therapeutic Innovation & Regulatory Science
|September 22, 2018
PubMed

Keywords:
ICHdrug registrationguidelinesharmonizationinterviewspharmaceutical development

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Some compounds produce hydroxide ions when dissolved by chemically reacting with water molecules. In all cases, these compounds react only partially and so are classified as weak bases. These types of compounds are also abundant in nature and important commodities in various technologies. For example, global production of the weak base ammonia is typically well over 100 metric tons annually, being widely used as an agricultural fertilizer, a raw material for chemical synthesis of other...
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Weak acids and bases do not undergo dissociation completely, and titrations between these two are rarely studied. When such studies are performed, say, for the titration of a weak acid with a weak base, the titration curve plots the change in pH as a function of the volume of base added. Take the titration of acetic acid with ammonia, for instance. During the titration, these two species form ammonium acetate and water, but the pH change is slow and gradual.
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