Search results with tag "Release oral"
Guideline on quality of oral modified release products
www.ema.europa.euIn general, prolonged release oral dosage forms should not have a score line because subdivision or other manipulation of modified release products may adversely affect the modified release properties of the dosage form, possibly leading to dose dumping. Any recommendation on subdivision of a modified release
Draft Note Guidance Investigation Bioavailability ...
www.ema.europa.eu5.1.3.Non-Oral Immediate Release forms with systemic action 13 5.1.4.Modified Release and transdermal dosage forms 13 5.1.5.Fixed combinations products 13 5.1.6.Parenteral solutions 13 5.1.7.Gases 13 5.1.8.Locally applied products 13 5.2. In Vitro Dissolution 14 5.3. Variations 14 5.4. Dose proportionality in immediate release oral dosage forms ...
BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED …
database.ich.orgimmediate-release oral dosage form with systemic action, and the drug product is dosage the same form and strength as the reference product. In cases where the highest single therapeutic dose does not meet the high solubility criterion but the highest strength of the reference product is soluble under the