Evolution of choice of solubility and dissolution media after two decades of biopharmaceutical classification system
N Bou-Chacra, KJC Melo, IAC Morales, ES Stippler… - The AAPS journal, 2017 - Springer
The introduction of the biopharmaceutics drug classification system (Biopharmaceutics
Classification System (BCS)), in 1995, provided a simple way to describe the …
Classification System (BCS)), in 1995, provided a simple way to describe the …
Crystalline solid dispersion-a strategy to slowdown salt disproportionation in solid state formulations during storage and wet granulation
Salt disproportionation (a conversion from the ionized to the neutral state) in solid
formulations is a potential concern during manufacturing or storage of products containing a …
formulations is a potential concern during manufacturing or storage of products containing a …
[图书][B] Handbook of preformulation: chemical, biological, and botanical drugs
SK Niazi - 2006 - taylorfrancis.com
Preformulation studies are the physical, chemical, and biological studies needed to
characterize a drug substance for enabling the proper design of a drug product, whereas the …
characterize a drug substance for enabling the proper design of a drug product, whereas the …
Mitigating the risks of generic drug product development: an application of quality by design (QbD) and question based review (QbR) approaches
M Kader - Journal of Excipients and Food Chemicals, 2016 - ojs.abo.fi
This paper discusses the challenges and opportunities of implementing the Quality by
Design (QbD) and Question based Review (QbR) approaches in developing solid dosage …
Design (QbD) and Question based Review (QbR) approaches in developing solid dosage …