Excipient
Found 8 free book(s)
Addressing specific regulatory excipient requirements in ...
ipec-europe.orgAddressing specific regulatory excipient requirements in the marketing authorization Dr. Philipp Hebestreit Global Regulatory Affairs Pharma Ingredients & Services
Pharmaceutical Excipients: A review
www.ijapbc.comwww.ijapbc.com IJAPBC – Vol. 1(1), Jan- Mar, 2012 23 Excipients affect the physicochemical characters of the active pharmaceutical
EVALUATION OF DRUG-EXCIPIENT INTERACTION IN THE ...
www.ptfarm.plEvaluation of drug-excipient interaction in the formulation of celecoxib tablets 425 obtain 692 mg tablets. The resistance to crushing of tablets was 68 ± 1.5 N.
Drug-excipient interaction and its importance in dosage ...
japsonline.comJournal of Applied Pharmaceutical Science 01 (06); 2011: 66-71 ISSN: 2231 Banjara Hills, Hyderabad Pharmaceutical dosage form is a combi b. Department of Quality assurance,
Excipient Master File Guide - ipecamericas.org
ipecamericas.orgThe International Pharmaceutical Excipients Council of the Americas Excipient Master File Guide
Excipient Audit Guideline - IPEC Europe
ipec-europe.orgJOINT IPEC-PQG GMP AUDIT GUIDELINE FOR PHARMACEUTICAL EXCIPIENTS GUIDELINE NOTES What is the system to assure that unneeded or obsolete documents are removed from
M4Q Implementation Working Group Questions & …
www.ich.org1. Introduction This document is intended to provide additional guidance for the preparation of an application file in the CTD-Q format (see section 2: General Issues).
DEFINITION OF ACTIVE PHARMACEUTICAL INGREDIENT
www.who.intWorking document QAS/11.426/Rev.1 page 3 DEFINITION OF ACTIVE PHARMACEUTICAL INGREDIENT Background In many WHO guidelines the following definition for an active pharmaceutical ingredient