Comprehensive draft guideline to combat smoking published by UK's NICE and PHE

2021 ◽  
Vol 882 (1) ◽  
pp. 27-27
Keyword(s):  
Draft Guideline

scholarly journals CHANGE MANAGEMENT OF DRUG PRODUCTS REGISTRATION CONDITIONS: NEW ICH Q12 GUIDELINE

2018 ◽  
Vol 73 (3) ◽  
pp. 181-189
Author(s):  
A. P. Meshkovskii ◽  
N. V. Pyatigorskaya ◽  
V. V. Beregovykh ◽  
Zh. I. Aladysheva ◽  
V. V. Belyaev ◽  
...  
Keyword(s):  
Change Management ◽  
Drug Product ◽  
Pharmaceutical Product ◽  
Product Lifecycle Management ◽  
Draft Guideline ◽  
Product Lifecycle ◽  
Regulatory Authorities ◽  
Management Protocol ◽  
Pharmaceutical Properties ◽  
Lifecycle Management

Introduction of amendments to the registration dossier is the responsibility of the marketing application holder (MAH). Increased knowledge on pharmaceuticals, its manufacturing and control processes can reduce the number of documents submitted to the regulatory authorities. The existing requirements establishing the procedure for the introduction of amendments differ in terms of change classification, period of notification of regulatory authorities, ways of conformity validation of pharmaceutical properties, etc. ICH proposed draft guideline Q12 «Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management» which covers the problem of harmonization of regulatory approaches to the changes provided in the «Quality» section of CTD during the commercial phase of drug life cycle. The new guideline can be considered as the continuation and elaboration of previous ICH documents. The article provides explanations on the main provisions and regulatory mechanisms introduced by the draft guideline ICH Q12: categorization of post-approval changes, established conditions, post-approval change management protocol, and drug product lifecycle management.

Workshop/Conference Report on EMA Draft Guideline on Validation of Bioanalytical Methods

2011 ◽  
Vol 42 (3) ◽  
pp. 300-305 ◽  
Author(s):  
Henning Blume ◽  
Erich Brendel ◽  
Margarete Brudny-Klöppel ◽  
Sylvia Grebe ◽  
Berthold Lausecker ◽  
...  
Keyword(s):  
Bioanalytical Methods ◽  
Conference Report ◽  
Draft Guideline

scholarly journals Statistical Methods for Quality Equivalence of Topical Products. 0.5 mg/g Betamethasone Ointment as a Case-Study

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 318 ◽  
Author(s):  
Jordi Ocaña ◽  
Toni Monleón-Getino ◽  
Virginia Merino ◽  
Daniel Peris ◽  
Lluís Soler
Keyword(s):  
Statistical Analysis ◽  
Confidence Interval ◽  
Physical Properties ◽  
Reference Product ◽  
Quality Parameters ◽  
European Medicines Agency ◽  
Draft Guideline ◽  
Equivalence Test ◽  
Test Product

This study examines the statistical implications, and their possible implementation, of the “Draft guideline on quality and equivalence of topical products” issued by the European Medicines Agency in 2018, with particular focus on the section devoted to quality equivalence of physical properties. A new confidence interval to conduct the quality equivalence test and a way to cope with the multiplicity of quality parameters are presented and discussed. As an example, the results and the statistical analysis of a study on betamethasone 0.5 mg/g ointment are presented. It is suggested that the equivalence limits proposed in the draft guideline are overly strict: It is as difficult to declare quality equivalence between two packaging formats of the same reference product as to declare quality equivalence between the reference and the test product.

Sufficiency of Reference Stress Solutions for FFS Evaluation of Crack-Like Flaws

2017 ◽  
Author(s):  
Kenji Oyamada ◽  
Naoki Miura
Keyword(s):  
High Pressure ◽  
Elevated Temperature ◽  
Comparative Study ◽  
Assessment Procedure ◽  
Bending Stress ◽  
Draft Guideline ◽  
Membrane Stress ◽  
Reference Stress ◽  
Standard Development

In Japan, a new standard of an assessment procedure for crack-like flaws in pressure equipment at elevated temperature is now under development in the High Pressure Institute of Japan (HPI). In this standard development, it is needed to adopt reference stress solutions for crack-like flaws in pressure equipment being subjected to membrane stress and/or bending stress. Such reference stress solutions have been proposed in various references such as ASME FFS-1/API579-1, BS7910, R5, FBR draft guideline, HPIS Z101-2, etc. A comparative study of those reference stress solutions was conducted in order to select appropriate one. As a result, reference stress solutions in HPIS Z101-2 were adopted. The sufficiency of adopted reference stress solutions was introduced in this paper. Also, the reference stress solutions for axially and circumferentially through-wall rectangular flawed cylinders, which were not provided in the HPIS Z101-2 standard but were utilized to derive those solutions adopted in the standard, were introduced in this paper. These solutions should be adopted in a new HPI standard for crack-like flaws in pressure equipment at elevated temperature.

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