100% tevredenheidsgarantie Direct beschikbaar na betaling Zowel online als in PDF Je zit nergens aan vast
Eerder door jou gezocht
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODU€13,67
In winkelwagen
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHN
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHN
Tentamen (uitwerkingen)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODU
1 keer bekeken 0 keer verkocht
Vak
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHN
Instelling
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHN
1.1 Objective of the Guideline
This guideline is intended to assist to the extent possible, in the establishment of a
single set of global specifications for new drug substances and new drug products. It
provides guidance on the setting and justification of acceptance criteria and the
selec...
international conference on harmonisation of techn
Geschreven voor
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHN
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHN
Verkoper
Volgen
Ariikelsey
Voorbeeld van de inhoud
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE
ICH HARMONISED TRIPARTITE GUIDELINE
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:
CHEMICAL SUBSTANCES
Q6A
Current Step 4 version
dated 6 October 1999
This Guideline has been developed by the appropriate ICH Expert Working Group and
has been subject to consultation by the regulatory parties, in accordance with the ICH
Process. At Step 4 of the Process the final draft is recommended for adoption to the
regulatory bodies of the European Union, Japan and USA.
, Q6A
Document History
New
First Codification
History Date
Codification November
2005
Q6A Approval by the Steering Committee under Step 2 18 Q6A
and release for public consultation. July
1997
Current Step 4 version
Q6A Approval by the Steering Committee under Step 4 and 6 Q6A
recommendation for adoption to the three ICH October
regulatory bodies. 1999
, SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:
CHEMICAL SUBSTANCES
ICH Harmonised Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting
on 6 October 1999, this guideline is recommended for
adoption to the three regulatory parties to ICH
TABLE OF CONTENTS
1. INTRODUCTION...................................................................................................... 1
1.1 Objective of the Guideline .............................................................................. 1
1.2 Background ..................................................................................................... 1
1.3 Scope of the Guideline .................................................................................... 1
2. GENERAL CONCEPTS ........................................................................................... 2
2.1 Periodic or Skip Testing ................................................................................. 2
2.2 Release vs. Shelf-life Acceptance Criteria ..................................................... 2
2.3 In-process Tests .............................................................................................. 3
2.4 Design and Development Considerations ..................................................... 3
2.5 Limited Data Available at Filing ................................................................... 3
2.6 Parametric Release ......................................................................................... 4
2.7 Alternative Procedures ................................................................................... 4
2.8 Pharmacopoeial Tests and Acceptance Criteria ........................................... 4
2.9 Evolving Technologies .................................................................................... 5
2.10 Impact of Drug Substance on Drug Product Specifications ......................... 5
2.11 Reference Standard ........................................................................................ 5
3. GUIDELINES ............................................................................................................ 5
3.1 Specifications: Definition and Justification .................................................. 5
3.1.1 Definition of Specifications ............................................................. 5
3.1.2 Justification of Specifications......................................................... 6
i
, Specifications: New Chemical Drug Substances and Products
3.2 Universal Tests / Criteria .............................................................................. 6
3.2.1 New Drug Substances .................................................................... 6
3.2.2 New Drug Products ........................................................................ 7
3.3 Specific Tests / Criteria .................................................................................. 8
3.3.1 New Drug Substances .................................................................... 8
3.3.2 New Drug Products ...................................................................... 10
Voordelen van het kopen van samenvattingen bij Stuvia op een rij:
Verzekerd van kwaliteit door reviews
Stuvia-klanten hebben meer dan 700.000 samenvattingen beoordeeld. Zo weet je zeker dat je de beste documenten koopt!
Snel en makkelijk kopen
Je betaalt supersnel en eenmalig met iDeal, creditcard of Stuvia-tegoed voor de samenvatting. Zonder lidmaatschap.
Focus op de essentie
Samenvattingen worden geschreven voor en door anderen. Daarom zijn de samenvattingen altijd betrouwbaar en actueel. Zo kom je snel tot de kern!
Veelgestelde vragen
Wat krijg ik als ik dit document koop?
Je krijgt een PDF, die direct beschikbaar is na je aankoop. Het gekochte document is altijd, overal en oneindig toegankelijk via je profiel.
Tevredenheidsgarantie: hoe werkt dat?
Onze tevredenheidsgarantie zorgt ervoor dat je altijd een studiedocument vindt dat goed bij je past. Je vult een formulier in en onze klantenservice regelt de rest.
Van wie koop ik deze samenvatting?
Stuvia is een marktplaats, je koop dit document dus niet van ons, maar van verkoper Ariikelsey. Stuvia faciliteert de betaling aan de verkoper.
Zit ik meteen vast aan een abonnement?
Nee, je koopt alleen deze samenvatting voor €13,67. Je zit daarna nergens aan vast.
