語系:
繁體中文
English
說明(常見問題)
登入
回首頁
切換:
標籤
|
MARC模式
|
ISBD
Solid Oral Dose Process Validation =...
~
Fredro-Kumbaradzi, Emilija.
Solid Oral Dose Process Validation = The Basics, Volume 1 /
紀錄類型:
書目-語言資料,印刷品 : Monograph/item
正題名/作者:
Solid Oral Dose Process Validation/ by Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins.
其他題名:
The Basics, Volume 1 /
作者:
Pazhayattil, Ajay Babu.
其他作者:
Sayeed-Desta, Naheed.
面頁冊數:
XIV, 92 p. 54 illus., 37 illus. in color.online resource. :
Contained By:
Springer Nature eBook
標題:
Pharmaceutical technology. -
電子資源:
https://doi.org/10.1007/978-3-030-02472-7
ISBN:
9783030024727
Solid Oral Dose Process Validation = The Basics, Volume 1 /
Pazhayattil, Ajay Babu.
Solid Oral Dose Process Validation
The Basics, Volume 1 /[electronic resource] :by Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins. - 1st ed. 2018. - XIV, 92 p. 54 illus., 37 illus. in color.online resource. - AAPS Introductions in the Pharmaceutical Sciences,2522-834X. - AAPS Introductions in the Pharmaceutical Sciences,.
Volume One.Preface -- Lifestyle Approach to Validation -- Solid Dose Formulations -- Stage 1A Process Design: Quality by Design -- Knowledge Management and Risk Assessment for Lifestyle Stages -- .Stage 1B Process and Scale Up Considerations -- Stage 2A and 2B Process Qualifications -- Stage 3A and 3B: Continued Process Verification.
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
ISBN: 9783030024727
Standard No.: 10.1007/978-3-030-02472-7doiSubjects--Topical Terms:
557391
Pharmaceutical technology.
LC Class. No.: RS380
Dewey Class. No.: 615.19
Solid Oral Dose Process Validation = The Basics, Volume 1 /
LDR
:03136nam a22004095i 4500
001
988290
003
DE-He213
005
20200702104417.0
007
cr nn 008mamaa
008
201225s2018 gw | s |||| 0|eng d
020
$a
9783030024727
$9
978-3-030-02472-7
024
7
$a
10.1007/978-3-030-02472-7
$2
doi
035
$a
978-3-030-02472-7
050
4
$a
RS380
050
4
$a
RS190-210
072
7
$a
TDCW
$2
bicssc
072
7
$a
MED072000
$2
bisacsh
072
7
$a
TDC
$2
thema
082
0 4
$a
615.19
$2
23
100
1
$a
Pazhayattil, Ajay Babu.
$4
aut
$4
http://id.loc.gov/vocabulary/relators/aut
$3
1210967
245
1 0
$a
Solid Oral Dose Process Validation
$h
[electronic resource] :
$b
The Basics, Volume 1 /
$c
by Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins.
250
$a
1st ed. 2018.
264
1
$a
Cham :
$b
Springer International Publishing :
$b
Imprint: Springer,
$c
2018.
300
$a
XIV, 92 p. 54 illus., 37 illus. in color.
$b
online resource.
336
$a
text
$b
txt
$2
rdacontent
337
$a
computer
$b
c
$2
rdamedia
338
$a
online resource
$b
cr
$2
rdacarrier
347
$a
text file
$b
PDF
$2
rda
490
1
$a
AAPS Introductions in the Pharmaceutical Sciences,
$x
2522-834X
505
0
$a
Volume One.Preface -- Lifestyle Approach to Validation -- Solid Dose Formulations -- Stage 1A Process Design: Quality by Design -- Knowledge Management and Risk Assessment for Lifestyle Stages -- .Stage 1B Process and Scale Up Considerations -- Stage 2A and 2B Process Qualifications -- Stage 3A and 3B: Continued Process Verification.
520
$a
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
650
0
$a
Pharmaceutical technology.
$3
557391
650
0
$a
Pharmacy.
$3
582411
650
1 4
$a
Pharmaceutical Sciences/Technology.
$3
768561
700
1
$a
Sayeed-Desta, Naheed.
$e
author.
$4
aut
$4
http://id.loc.gov/vocabulary/relators/aut
$3
1280577
700
1
$a
Fredro-Kumbaradzi, Emilija.
$e
author.
$4
aut
$4
http://id.loc.gov/vocabulary/relators/aut
$3
1280578
700
1
$a
Collins, Jordan.
$e
author.
$4
aut
$4
http://id.loc.gov/vocabulary/relators/aut
$3
1280579
710
2
$a
SpringerLink (Online service)
$3
593884
773
0
$t
Springer Nature eBook
776
0 8
$i
Printed edition:
$z
9783030024710
776
0 8
$i
Printed edition:
$z
9783030024734
830
0
$a
AAPS Introductions in the Pharmaceutical Sciences,
$x
2522-834X
$3
1280580
856
4 0
$u
https://doi.org/10.1007/978-3-030-02472-7
912
$a
ZDB-2-SBL
912
$a
ZDB-2-SXB
950
$a
Biomedical and Life Sciences (SpringerNature-11642)
950
$a
Biomedical and Life Sciences (R0) (SpringerNature-43708)
筆 0 讀者評論
多媒體
評論
新增評論
分享你的心得
Export
取書館別
處理中
...
變更密碼[密碼必須為2種組合(英文和數字)及長度為10碼以上]
登入