ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms-Reference-Cited by-同舟云学术

ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms

Published:2017-09-29 Issue: Volume: Page:3-44
ISSN:
Container-title:ICH Quality Guidelines
language:
Short-container-title:

Author:

Rignall Andy¹

Affiliation:

1. AstraZeneca; London UK

Publisher

John Wiley & Sons, Inc.

Reference54 articles.

1. ICH Q1A(R2) 2003 Stability Testing of New Drug Substances and Products (Revised Guideline)

2. ICH Q1C 1996 Stability Testing of New Dosage Forms

3. World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

4. ICH Q8 (R2) 2009 Pharmaceutical Development (Revised Guideline)

5. ICH Q9 2006 Quality Risk Management

Cited by 22 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Study of inhalation micropowders obtained by spray drying;Fine Chemical Technologies;2024-09-11

2. A review of the physiological effects of microgravity and innovative formulation for space travelers;Journal of Pharmacokinetics and Pharmacodynamics;2024-08-20

3. Application of Response Surface Methodology Using Face-centered Central Composite Design for Studying Long-Term Stability of Gliclazide-Loaded Multiparticulate Systems;Journal of Pharmaceutical Sciences;2024-08

4. Evaluation of the Greenness, Whiteness, and blueness profiles of stability indicating HPLC method for determination of Denaverine hydrochloride and benzyl alcohol in pharmaceuticals;Microchemical Journal;2024-06

5. Development and efficacy assessment of polyherbal phytosomal gel for accelerated wound healing;Journal of Biomaterials Science, Polymer Edition;2024-05-03