Übersicht			Auf mobile öffnen

Lieferstatus:	Auf Bestellung (Lieferzeit unbekannt)
Veröffentlichung:	September 2019
Genre:	Naturwissensch., Medizin, Technik
	B / Biomedical and Life Sciences / Pharmacology / Pharmacology/Toxicology / Pharmacy / Pharmacy / dispensing
ISBN:	9783030274832
EAN-Code:	9783030274832
Verlag:	Springer Nature EN
Einband:	Gebunden
Sprache:	English
Serie:	AAPS Introductions in the Pharmaceutical Sciences
Dimensionen:	H 235 mm / B 155 mm / D
Gewicht:	354 gr
Seiten:	108
Illustration:	XII, 108 p. 83 illus., 60 illus. in color., schwarz-weiss Illustrationen, farbige Illustrationen
Bewertung:	Titel bewerten / Meinung schreiben

Inhalt:

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validationlifecycle approach. This set is published as a comprehensive solution for solid dose process validation.