Open access
Oct 2026
Risk-based approach to excipient selection: a case study of an original drug product
Background. GML-3 is a promising non benzodiazepine anxiolytic with antidepressant activity, but its poor water solubility and flowability complicate the development of an oral solid dosage form. Modern regulatory requirements (ICH Q8–Q10) mandate systematic risk assessment throughout development, making a risk base...
S. P. Tishkov, D. Vuynovich, V. Markeev et al.
· Pharmacokinetics and Pharmac... · 0 citations