8 research outputs found
The Principles of Freeze-Drying
- Author
- A Petersen
- AA Adebayo
- AP Mackenzie
- B Fanget
- B Grout
- BWW Grout
- C Bindschaedler
- CA Morgan
- Center for Biologies Evaluation and Research
- CS Cox
- CW Griffin
- D Awotwe-Otoo
- D Greiff
- D Greiff
- D Greiff
- D Greiff
- E Rizzo de
- F Franks
- F Franks
- F Franks
- F Franks
- F Franks
- G Oetjen
- GDJ Adams
- GDJ Adams
- GDJ Adams
- GDJ Adams
- GDJ Adams
- GDJ Adams
- GDJ Adams
- GO Phillips
- H Levine
- H Willemer
- HI Meryman
- IA Cook
- J Farrant
- JF Carpenter
- KA Cammack
- LR Rey
- M Bellissent-Funel
- M Gheorghiu
- MJ Pikal
- MJ Pikal
- MJ Taylor
- MT Ashwood-Smith
- P Cameron
- P Mazur
- PT Beale
- R Geidobler
- RG Livesey
- RJ Bellows
- RJ Heckly
- S Passot
- S Tsourouflis
- SM Patel
- T Arakawa
- TA Jennings
- TW Patapoff
- TWG Rowe
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Determination of End Point of Primary Drying in Freeze-Drying Process Control
- Author
- Publication venue
- Springer US
- Publication date
- Field of study
Freeze-drying is a relatively expensive process requiring long processing time, and hence one of the key objectives during freeze-drying process development is to minimize the primary drying time, which is the longest of the three steps in freeze-drying. However, increasing the shelf temperature into secondary drying before all of the ice is removed from the product will likely cause collapse or eutectic melt. Thus, from product quality as well as process economics standpoint, it is very critical to detect the end of primary drying. Experiments were conducted with 5% mannitol and 5% sucrose as model systems. The apparent end point of primary drying was determined by comparative pressure measurement (i.e., Pirani vs. MKS Baratron), dew point, Lyotrack (gas plasma spectroscopy), water concentration from tunable diode laser absorption spectroscopy, condenser pressure, pressure rise test (manometric temperature measurement or variations of this method), and product thermocouples. Vials were pulled out from the drying chamber using a sample thief during late primary and early secondary drying to determine percent residual moisture either gravimetrically or by Karl Fischer, and the cake structure was determined visually for melt-back, collapse, and retention of cake structure at the apparent end point of primary drying (i.e., onset, midpoint, and offset). By far, the Pirani is the best choice of the methods tested for evaluation of the end point of primary drying. Also, it is a batch technique, which is cheap, steam sterilizable, and easy to install without requiring any modification to the existing dryer
Effect of Sugars, Surfactant, and Tangential Flow Filtration on the Freeze-Drying of Poly(lactic acid) Nanoparticles
- Author
- A Saez
- A-M Layre
- C Schwarz
- D Quintanar-Guerrero
- F Jaeghere de
- F Jaeghere de
- G Dalwadi
- G Dalwadi
- GB Sukhorukov
- GDJ Adams
- H Fessi
- I Limayem
- JC Zillies
- JF Carpenter
- Jouni Hirvonen
- Leena Peltonen
- M Chacón
- MdC Luzardo
- MF Zambaux
- MG Anhorn
- Millipore Corporation
- MJ Choi
- P Couvreur
- R Cavalli
- S Chasteigner de
- S Hirsjärvi
- S Hirsjärvi
- S Hirsjärvi
- Samuli Hirsjärvi
- SD Singh-Joy
- V Kokol
- W Abdelwahed
- W Abdelwahed
- W Abdelwahed
- Y-I Jeong
- YN Konan
- Publication venue
- Springer US
- Publication date
- Field of study
Poly(d,l-lactic acid) nanoparticles were freeze-dried in this study. With respect to drying, effect of protective excipients and purification from excess surfactant were evaluated. The nanoparticles were prepared by the nanoprecipitation method with or without a surfactant, poloxamer 188. The particles with the surfactant were used as such or purified by tangential flow filtration. The protective excipients tested were trehalose, sucrose, lactose, glucose, poloxamer 188, and some of their combinations. The best freeze-drying results in terms of nanoparticle survival were achieved with trehalose or sucrose at concentrations 5% and 2% and, on the other hand, with a combination of lactose and glucose. Purification of the nanoparticle dispersion from the excess surfactant prior to the freeze-drying by tangential flow filtration ensured better drying outcome and enabled reduction of the amount of the protective excipients used in the process. The excess surfactant, if not removed, was assumed to interact with the protective excipients decreasing their protective mechanism towards the nanoparticles
History of Vaccine Process Development
- Author
- Adams GDJ
- Aunins JG
- Aunins JG
- Bailey A
- Behbehani AM
- Billich A
- Blyden ER
- Burgener A
- Butler M
- Clark TG
- Dalemans W
- Dekleva ML
- Dekleva ML
- Dietrich G
- Elliott AY
- Ellis RW
- El‐Mansi EMT
- Giuliani SE
- Glenny AT
- Hayflick L
- Jayapal KP
- Junker B
- La Montagne JR
- Langenberg AG
- Lindberg AA
- Merten OW
- Murasugi A
- Ozturk SS
- Rappuoli R
- Ravetkar SD
- Schwick HG
- Scott C
- Shevitz J
- Spaete RR
- Surjan M
- Vainio J
- Whitford WG
- Woodruff AM
- Publication venue
- 'Wiley'
- Publication date
- Field of study
Using mathematical modeling and prior knowledge for QbD in freeze-drying processes
- Author
- A Giordano
- AA Alexeenko
- AA Barresi
- AA Barresi
- AA Barresi
- AI Liapis
- AI Liapis
- AI Liapis
- AI Liapis
- B Woinet
- BC Hancock
- BS Chang
- D Fissore
- D Fissore
- D Fissore
- DQ Wang
- DS Reid
- F Franks
- G Baldi
- GDJ Adams
- GEP Box
- GK Batchelor
- GW Oetjen
- GW Oetjen
- GW Oetjen
- H Gieseler
- H Sadikoglu
- H Ybema
- J Searles
- JA Goff
- JA Searles
- JA Searles
- JC Maxwell
- JH Boer De
- JH Boer De
- JI Lombraña
- JL Bomben
- K Nakagawa
- KH Gan
- KH Gan
- LM Hardwick
- M Brülls
- M Knudsen
- M Kochs
- M Kochs
- MJ Millman
- MJ Pikal
- MJ Pikal
- MJ Pikal
- MJ Pikal
- MJ Pikal
- MJ Pikal
- N Milton
- P Chouvenc
- P Sheehan
- R Pisano
- R Pisano
- RJ Bellows
- S Chapman
- S Corbellini
- S Tsourouflis
- SA Velardi
- SA Velardi
- SL Nail
- SM Patel
- SV Sane
- V Rasetto
- W Kurz
- WJ Mascarenhas
- WY Kuu
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 01/01/2015
- Field of study
Angeborene Herz- und Gefäßfehler
- Author
- A Abrikosoff
- A Abrikosoff
- A Anderson
- A Arkin
- A Arkin
- A Arnstein
- A Azevedo
- A Azevedo de
- A Babey
- A Babey
- A Battro
- A Beuren
- A Bigo
- A Blackhall-Morison
- A Blalock
- A Blalock
- A Blalock
- A Breton
- A Bruwer
- A Bruwer
- A Castellanos
- A Castellanos
- A Castellanos
- A Castellanos
- A Castellanos
- A Castellanos
- A Christie
- A Costa
- A Costa
- A Costa
- A Cournand
- A Cournand
- A Cournand
- A Cramer
- A Dalton
- A Dekker
- A Düx
- A Epstein
- A Esser
- A Fallot
- A Fink
- A Fitzgerald
- A Franceschetti
- A Ghon
- A Gonin
- A Gousios
- A Graybiel
- A Grishman
- A Grishman
- A Guggenheim
- A Heckler
- A Heigel
- A Himmelstein
- A Hotz
- A Jackson
- A Josefson
- A Keith
- A Keith
- A Keith
- A Kerr Jr.
- A Keys
- A Leatham
- A Leatham
- A Murray
- A Nagel
- A Obiditsch
- A Passow
- A Pontes
- A Rados
- A Ravelli
- A Ravin
- A Renander
- A Robinson
- A Sanderud
- A Schaede
- A Schaede
- A Schaede
- A Schaede
- A Schaede
- A Schaede
- A Schmincke
- A Segondi
- A Selzer
- A Selzer
- A Selzer
- A Senning
- A Senning
- A Sjoerdsma
- A Spitzer
- A Spitzer
- A Spitzer
- A Stecken
- A Stecken
- A Sturm
- A Sturm Jr.
- A Testini
- A Thomson
- A Tourniaire
- A Tourniaire
- A Vass
- A Vineberg
- A Vogt
- A Zink
- AA Fischl
- AA Peel
- AA Peel
- AA Zimmermann
- AB Burchell
- AB Ford
- AB Kelly
- AB Marfan
- AC Papaioannou
- AC Rambar
- AC Witham
- AD Nichol
- AD Nichol
- AD Waller
- AE Doyle
- AE Sansom
- AE Schmid
- AE Ungerleider
- AEJ Barclay
- AG Dato
- AG Morrow
- AG Morrow
- AGW Whitfield
- AI Blake
- AJ Aballi
- AJ Beuren
- AJ Beuren
- AJ Beuren
- AJ Beuren
- AJ Beuren
- AJ Bruwer
- AJ Bruwer
- AJ Geiger
- AJ Glazebrook
- AJ Kerwin
- AJ Sweyer
- AL d’Abreu
- AL D’abreu
- AL Friedlich
- Albracht
- AM Jones
- AM McCallen
- AM Olsen
- AM Rogers
- AR Diaz
- AR Gilchrist
- AR Gilchrist
- AR Higgins
- AR Muir
- AS Nadas
- AS Nadas
- AS Parker
- ASW Touroff
- AT Bahnson
- AW Baughart
- AW Ormond
- AW Silver
- AW Tucker
- AW Venables
- B Adachi
- B Baginsky
- B BrodÉn
- B Conrads
- B Felson
- B Halpert
- B Halpert
- B Halpert
- B Hartmann
- B Hellstroem
- B Kommerell
- B Levin
- B Lingen van
- B Perry
- B Preter
- B Richman
- B Stackelberg
- B Taschen
- B Thurnher
- B Zuber
- BA Bercu
- Barnard
- BD Bower
- BE Taylor
- BE Taylor
- BF Vaugham
- BI Ivemark
- BJ Anson
- BL Brofman
- BM Gasul
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- BM Kaplan
- BM Patten
- BO Price
- Bolders
- BS Tabakin
- Buchem
- Buchem
- BV Jager
- C Bakken
- C Crafoord
- C Davis Jr.
- C Denton
- C Ferencz
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- C Gerhardt
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- C Goetsch
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- Cassel
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- D Bauer
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- E Apert
- E Araya
- E Braunwald
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- E Cockayne
- E Custodis
- E Derra
- E Derra
- E Derra
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- E Derra
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- E Evans
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- E Kaiser
- E Kirch
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- E Mannheimer
- E Mannheimer
- E Mannheimer
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- E Pfennig
- E Richards
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- E Stutz
- E Thomas
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- E Weiss
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- EZ Pernkopf
- F Bender
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- F Grosse-Brockhoff
- F Grosse-Brockhoff
- F Grosse-Brockhoff
- F Grosse-Brockhoff
- F Grosse-Brockhoff
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- — Die Mißbildungen des menschlichen Herzens. Ergebn. allg. Path. path
- —La double crosse aortique
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 01/01/1967
- Field of study
Evolocumab and clinical outcomes in patients with cardiovascular disease
- Author
- Abelson M
- Aboufakher R
- Abrahamsen Te
- Accini Mendoza Jl
- Acheatel R
- Ackermann D
- Adamkova V
- Adams M
- Adlam D
- Aggarwal R
- Aggarwal S
- Ahsan A
- Ainsworth P
- Airody Govinda R
- Akai A
- Ako J
- Al-Bahrani A
- Al-Joundi T
- Aldegather J
- Aldrete Velasco Ja
- Alfieri A
- Alt I
- Alzohaili O
- Amerena J
- Amin J
- Amoedo R
- Amuchastegui M
- Anderson T
- Andreka P
- Andreotti F
- Angoulvant D
- Ansell B
- Antalik L
- Antkowiak-Piatyszek K
- Appel K
- Arakawa T
- Arana Londoño C
- Ardissino D
- Ardito Wr
- Arkhipov M
- Arsenescu-Georgescu C
- Asamoah N
- Ascaso Gimilio Jf
- Atar S
- Atassi K
- Athyros V
- Auerbach E
- Awtry E
- Baass A
- Badariene J
- Badat A
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- Baigent C
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- Wozniak I
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- Yakhontova P
- Yamamoto K
- Yamashita K
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- Yao Z
- Yasumura Y
- Yataco A
- Yeh H
- Yena L
- Yeoman G
- Yigit Z
- Yilmaz Mb
- Yokoya K
- Yoshimichi G
- Yotov Y
- Youngman D
- Younis L
- Yuge M
- Zabowka M
- Zahn L
- Zamorano Gomez Jl
- Zarich S
- Zateyshchikov D
- Zdrenghea D
- Zechowicz T
- Zeig S
- Zemanek J
- Zeng X
- Zhang L
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- Zheng Y
- Zheng Z
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- Ziegler O
- Zilahi Z
- Zrazhevskiy K
- Östergren J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets
Enzyme Handbook
- Author
- 339-349
- [10]Siffert O., Emöd, I.
- [11] Fricker L.D., Snyder, S.H.
- [11] Taylor A., Volz, K.W., Lipscomb, W.N., Takemoto, L. J.
- [3] Schmidt U., Weller, D., Holder, A.
- [9]Fujiwara K., Tsuru, D.
- [hie J.N., Dure, L.S.
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- Y Banno
- Y Birk
- Y Dasarathy
- Y Dupont
- Y Ethoh
- Y Etoh
- Y Hara
- Y Hashitani
- Y Hirashima
- Y Hirashima
- Y Hojima
- Y Hojima
- Y Inaoka
- Y Ishizaki
- Y Isowa
- Y Isowa
- Y Ito
- Y Kagawa
- Y Katsuya
- Y Kawaguchi
- Y Kido
- Y Kido
- Y Kim
- Y Kohama
- Y Komori
- Y Kubota
- Y Kubota
- Y Kuriyama
- Y Levin
- Y Looze
- Y Minami
- Y Miura
- Y Mizuno
- Y Mukohata
- Y Nagai
- Y Nagai
- Y Nagai
- Y Nagai
- Y Nakagawa
- Y Nakajima
- Y Narahashi
- Y Nishimura
- Y Nishimura
- Y Ohba
- Y Ohba
- Y Ohno-Iwashita
- Y Ohno-Iwashita
- Y Ohta
- Y Otsuka
- Y Sanada
- Y Shimamori
- Y Shimamori
- Y Sook Shin
- Y Takada
- Y Takii
- Y Takii
- Y Tamura
- Y Tiffon
- Y Tsujita
- Y Tsujita
- Y Tsujita
- Y Tsujita
- Y Tsujita
- Y Tsujita
- Y Tsujita
- Y Tsujita
- Y Vanneste
- Y Wang
- Y Watanabe
- Y Yano
- Y Yasuda
- Y-R Chen
- Y-R Chen
- YJ Kao
- YK Hopsu-Havu
- YP Kim
- YP Loh
- YS Kim
- YV Mitin
- Z Bohak
- Z Kucerova
- Z Wasylewski
- “ (Turk V., Neville, M.
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- 01/01/1991
- Field of study