4.4 Article

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Article Medicine, Research & Experimental

An Expert System To Predict the Forced Degradation of Organic Molecules

Alexis D. C. Parenty et al.

MOLECULAR PHARMACEUTICS (2013)

Article Chemistry, Medicinal

The use of N-methylpyrrolidone as a cosolvent and oxidant in pharmaceutical stress testing

Dan W. Reynolds et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2012)

Editorial Material Chemistry, Medicinal

A Critical Assessment of the ICH Guideline on Photostability Testing of New Drug Substances and Products (Q1B): Recommendation for Revision

Steven W. Baertschi et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2010)

Article Medicine, Legal

An evaluation of chemical photoreactivity and the relationship to phototoxicity

Mark H. Kleinman et al.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2010)

Article Biochemistry & Molecular Biology

Can light absorption and photostability data be used to assess the photosafety risks in patients for a new drug molecule?

Brian Henry et al.

JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY B-BIOLOGY (2009)

Article Respiratory System

Characterization of nebulized liposomal amikacin (Arikace™) as a function of droplet size

Zhili Li et al.

JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY (2008)

Article Biophysics

Peroxidation of liposomal lipids

Edit Schnitzer et al.

EUROPEAN BIOPHYSICS JOURNAL WITH BIOPHYSICS LETTERS (2007)

Article Chemistry, Multidisciplinary

Improved protocol and data analysis for accelerated shelf-life estimation of solid dosage forms

Kenneth C. Waterman et al.

PHARMACEUTICAL RESEARCH (2007)

Review Pharmacology & Pharmacy

The role of degradant profiling in active pharmaceutical ingredients and drug products

Karen M. Alsante et al.

ADVANCED DRUG DELIVERY REVIEWS (2007)

Article Chemistry, Medicinal

Evaluation of hydroperoxides in common pharmaceutical excipients

Walter R. Wasylaschuk et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2007)

Article Chemistry, Analytical

Analytical methodologies for discovering and profiling degradation-related impurities

Steven W. Baertschi

TRAC-TRENDS IN ANALYTICAL CHEMISTRY (2006)

Article Chemistry, Multidisciplinary

In vivo ESR studies on subcutaneously injected multilamellar liposomes in living mice

KP Moll et al.

PHARMACEUTICAL RESEARCH (2004)

Article Chemistry, Analytical

Determination of relative UV response factors for HPLC by use of a chemiluminescent nitrogen-specific detector

MA Nussbaum et al.

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2002)