Quality concept of parenterals in Europe
H Möller - PDA Journal of Pharmaceutical Science and …, 1995 - journal.pda.org
Different types of dosage forms are available for parenteral use. They include solutions and
suspensions for injection and infusion, sterile powders and lyophilisates which are …
suspensions for injection and infusion, sterile powders and lyophilisates which are …
Quality requirements and analysis
O Smeets, M Santillo, H van Rooij - … for the Preparation, Care and Use of …, 2015 - Springer
For the control of the production of medicines quality requirements are essential. Quality
requirements cover the quality of the preparation throughout the whole shelf life, from …
requirements cover the quality of the preparation throughout the whole shelf life, from …
Quality Requirements and Analysis
M Santillo, F Lagarce - … Pharmaceutics: An International Guideline for the …, 2023 - Springer
For the control of the production of medicines quality requirements are essential. Quality
requirements cover the quality of the preparation throughout the whole shelf life, from …
requirements cover the quality of the preparation throughout the whole shelf life, from …
Raw Materials
R Lantink, M Hörnig - … Pharmaceutics: An International Guideline for the …, 2023 - Springer
Raw materials for pharmaceutical preparations are either active substances (or active
pharmaceutical ingredients (APIs)) or excipients. The choice of excipients and the quality of …
pharmaceutical ingredients (APIs)) or excipients. The choice of excipients and the quality of …
Quality and functionality of excipients
G Pifferi, P Santoro, M Pedrani - Il Farmaco, 1999 - Elsevier
The quality of medicines depends not only on the active principles and production
processes, but also the performance of the excipients. The traditional concept of the …
processes, but also the performance of the excipients. The traditional concept of the …
Drug substance and excipient characterization
PWS Heng, LW Chan - Drugs and the pharmaceutical sciences, 1997 - books.google.com
Characterization of drug substances and excipients is a very important step at the
preformulation phase of product development. Although testing will involve additional time …
preformulation phase of product development. Although testing will involve additional time …
Development pharmaceutics and process validation
JM Morris, MR Pharm - Drug Development and Industrial …, 1990 - Taylor & Francis
A resume is presented of the guideline on the data required under Part IA 4. of the Annex to
European Directive 75/318/EEC covering the choice of composition of a medicinal product …
European Directive 75/318/EEC covering the choice of composition of a medicinal product …
The interchangeability of excipient formulations and the eventual consequences
P Maincent - Therapie, 1999 - europepmc.org
Excipients are used to prepare dosage forms in order to facilitate the administration and the
efficacy of drugs through better handling of the manufacturing process and an increase in …
efficacy of drugs through better handling of the manufacturing process and an increase in …
Raw materials
R Bouwman, R Bateman - … : An International Guideline for the Preparation …, 2015 - Springer
Raw materials for pharmaceutical preparations are either active substances (or active
pharmaceutical ingredients: APIs) or excipients. The choice of excipients and the quality of …
pharmaceutical ingredients: APIs) or excipients. The choice of excipients and the quality of …
The Quality Regulation of Drug Excipients
MS Choi, CH Hong, SJ Jang… - Journal of Pharmaceutical …, 2003 - koreascience.kr
Drug excipients are material used in the formulation of pharmacologically active drugs. They
have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives …
have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives …