법령 및 고시
가이드 라인 : 용출시험법
| 작성자 | 관리자 | ||
|---|---|---|---|
| 작성일 | 2016-06-30 | 조회수 | 2,358 |
| 국가정보 | 아프리카>남아프리카공화국 | ||
| 출처 | 한국보건산업진흥원 | ||
| 원문 | |||
| 첨부파일 | |||
Guideline Dissolution.pdf(332.18KB)abstract
This guideline describes the setting of dissolution specifications as a quality control requirement and also describes how to conduct dissolution testing in support of a request for a waiver for bioequivalence testing.
The various types of changes where dissolution can be used in support of a biowaiver are described in the Post-Registration Amendment guideline (IDRAC 109814).
The guideline contents are:
- Setting dissolution specifications for immediate release solid oral dosage forms
- Comparison of dissolution profiles
- In vitro dissolution testing in support of a biowaiver.
This guideline version provides clarification in line with CPMP/QWP/604/96 EMEA 1999 and CPMP/EWP/QWP/1401/98 Rev. 1/ Corr (IDRAC 120848) in sections 2 and 3, updating of reporting requirements, also for non-comparative studies in line with P&A guideline, clarification of Type C for easy reference, updating of reference.
