FORCED DEGRADATION STUDIES: PRACTICAL APPROACH - OVERVIEW OF REGULATORY GUIDANCE AND LITERATURE FOR THE DRUG PRODUCTS AND DRUG SUBSTANCES Journal title: International Research Journal of Pharmacy (IRJP) Authors: Kishore Hotha, Satti Phani Reddy, L.K. Ravindranath Subject(s):
REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING Journal title: International Journal of Drug Regulatory Affairs Authors: Kothari Charmy, Shah Kavina Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance Journal title: The AAPS Journal Authors: Brian Booth, Mark E. Arnold, Binodh DeSilva, Lakshmi Amaravadi, Sherri Dudal, Eric Fluhler, Boris Go... Subject(s): Medicine
Acceptance Probability (Pa) Analysis for Process Validation Lifecycle Stages Journal title: AAPS PharmSciTech Authors: Daniel Alsmeyer, Ajay Pazhayattil, Shu Chen, Francesco Munaretto, Maksuda Hye, Pradeep Sanghvi Subject(s): Medicine
Comparison of In Vitro Release Rates of Acyclovir from Cream Formulations Using Vertical Diffusion Cells Journal title: AAPS PharmSciTech Authors: Sumalatha Nallagundla, Srinivas Patnala, Isadore Kanfer Subject(s): Medicine
