-
2
-
-
33845450076
-
-
Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals Annex 7. (accessed on July 28, 2011)
-
Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals. WHO Technical Report Series No 908, 2003 Annex 7. http://apps.who.int/medicinedocs/en/d/Js5517e/23.html (accessed on July 28, 2011).
-
(2003)
WHO Technical Report Series No 908
-
-
-
3
-
-
84984084727
-
Water vapour transmission properties of applied polymer films
-
G.S. Banker, A.Y. Gore, and J. Swarbrick Water vapour transmission properties of applied polymer films J. Pharm. Pharmacol. 18 1966 205S 211S
-
(1966)
J. Pharm. Pharmacol.
, vol.18
-
-
Banker, G.S.1
Gore, A.Y.2
Swarbrick, J.3
-
4
-
-
77958088811
-
Design space of pharmaceutical processes using data-driven-based methods
-
F. Boukouvala, F.J. Muzzio, and M.G. Ierapetritou Design space of pharmaceutical processes using data-driven-based methods J. Pharm. Innov. 5 2010 119 137
-
(2010)
J. Pharm. Innov.
, vol.5
, pp. 119-137
-
-
Boukouvala, F.1
Muzzio, F.J.2
Ierapetritou, M.G.3
-
5
-
-
84856545074
-
-
British Pharmacopeia Convention, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, BP 2009.
-
British Pharmacopeia Convention, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, BP 2009.
-
-
-
-
6
-
-
84856548436
-
-
British standard BS: IEC61882:2002 Hazard and operability studies (HAZOP studies) - application guide British standards institution. This British standard reproduces verbatim IEC 61882:2001 and implements it as the UK national standard.
-
British standard BS: IEC61882:2002 Hazard and operability studies (HAZOP studies) - application guide British standards institution. This British standard reproduces verbatim IEC 61882:2001 and implements it as the UK national standard.
-
-
-
-
7
-
-
84856558997
-
-
(accessed on July 28, 2011).
-
http://www.ingenieroambiental.com/4002/ BS%20IEC%2061882%202001%20HAZOP%20guide.pdf (accessed on July 28, 2011).
-
-
-
-
8
-
-
0000496231
-
Evaluating flow properties of solids
-
R.L. Carr Jr. Evaluating flow properties of solids Chem. Eng. 18 1965 163 166
-
(1965)
Chem. Eng.
, vol.18
, pp. 163-166
-
-
Carr, Jr.R.L.1
-
9
-
-
67349237855
-
Biowaiver monographs for immediate release solid oral dosage forms: Diclofenac sodium and diclofenac potassium
-
B. Chuasuwan, V. Binjesoh, J.E. Polli, H. Zhang, G.L. Amidon, H.E. Junginger, K.K. Midha, V.P. Shah, S. Stavchansky, J.B. Dressman, and D.M. Barends Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and diclofenac potassium J. Pharm. Sci. 98 2009 1206 1219
-
(2009)
J. Pharm. Sci.
, vol.98
, pp. 1206-1219
-
-
Chuasuwan, B.1
Binjesoh, V.2
Polli, J.E.3
Zhang, H.4
Amidon, G.L.5
Junginger, H.E.6
Midha, K.K.7
Shah, V.P.8
Stavchansky, S.9
Dressman, J.B.10
Barends, D.M.11
-
10
-
-
0031936142
-
Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine
-
D.W. David, W.B. Steven, A.J. Ross, R.M. Steven, S.M. Marybeth, K.H. Diana, and M.G. Stephen Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine J. Pharm. Sci. 87 1998 31 39
-
(1998)
J. Pharm. Sci.
, vol.87
, pp. 31-39
-
-
David, D.W.1
Steven, W.B.2
Ross, A.J.3
Steven, R.M.4
Marybeth, S.M.5
Diana, K.H.6
Stephen, M.G.7
-
11
-
-
84856548015
-
Target product profile: Beginning drug development with the end in mind
-
J.M. Delasko, D.M. Cocchetto, and L.B. Burke Target product profile: beginning drug development with the end in mind Update 1 2005 36 39
-
(2005)
Update
, vol.1
, pp. 36-39
-
-
Delasko, J.M.1
Cocchetto, D.M.2
Burke, L.B.3
-
12
-
-
84856558996
-
-
EMEA/CHMP/QWP/811210/2009 Rev 1, 25 February 2010. (accessed on July 28, 2011)
-
EMEA Guideline on real time release testing. EMEA/CHMP/QWP/811210/2009 Rev 1, 25 February 2010. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2010/03/WC500075028.pdf (accessed on July 28, 2011).
-
EMEA Guideline on Real Time Release Testing
-
-
-
14
-
-
0042557758
-
-
sec. 201(p)(1), sec. 201(p)(2), 21 U.S.C. 321(p)(1), (p)(2); Pub. L.
-
Federal Food, Drug and Cosmetic Act (FDCA), 1962. sec. 201(p)(1), sec. 201(p)(2), 21 U.S.C. 321(p)(1), (p)(2); Pub. L., pp. 87-781.
-
(1962)
Federal Food, Drug and Cosmetic Act (FDCA)
, pp. 87-781
-
-
-
16
-
-
27044432974
-
-
Public Law 59-384. 34 U.S. Stat. 30 June
-
Food and Drugs Act of 1906. Public Law 59-384. 34 U.S. Stat. 30 June 1906, 768.
-
(1906)
Food and Drugs Act of 1906
, pp. 768
-
-
-
17
-
-
84856554676
-
-
Part III, 1962 Drug Amendments, FDA Consumer, June (available on FDA website; Part 3 history1b)
-
Janssen, W.F., 1981. The Story of the Laws Behind the Labels, Part I, 1906 Food and Drugs Act, Part II, 1938 The Federal Food, Drug, and Cosmetic Act., Part III, 1962 Drug Amendments, FDA Consumer, June (available on FDA website; Part 3 history1b).
-
(1981)
The Story of the Laws behind the Labels, Part I, 1906 Food and Drugs Act, Part II, 1938 the Federal Food, Drug, and Cosmetic Act
-
-
Janssen, W.F.1
-
22
-
-
84856548438
-
-
(accessed on July 29)
-
http://www.fda.gov/cder/gmp/gmp2004/GMP-finalreport2004.htm (accessed on July 29).
-
-
-
-
24
-
-
40149110058
-
Process robustness - A PQRI white paper
-
M. Glodek, S. Liebowitz, R. McCarthy, G. Mcnally, C. Oksanen, and T. Schultz Process robustness - a PQRI white paper Pharm. Eng. 2006 1 11
-
(2006)
Pharm. Eng.
, pp. 1-11
-
-
Glodek, M.1
Liebowitz, S.2
McCarthy, R.3
McNally, G.4
Oksanen, C.5
Schultz, T.6
-
25
-
-
0036090498
-
Risk filtering, ranking, and management framework using hierarchical holographic modeling
-
DOI 10.1111/0272-4332.00020
-
Y.Y. Haimes, S. Kaplan, and J.H. Lambert Risk filtering, ranking, and management framework using hierarchical holographic modelling Risk Anal. 22 2002 383 397 (Pubitemid 34533265)
-
(2002)
Risk Analysis
, vol.22
, Issue.2
, pp. 383-397
-
-
Haimes, Y.Y.1
Kaplan, S.2
Lambert, J.H.3
-
27
-
-
70350208809
-
Quality by design case study: An integrated multivariate approach to drug product and process development
-
J. Huang, G. Kaul, C. Cai, R. Chatlapalli, P.H. Abad, K. Ghosh, and A. Nagi Quality by design case study: an integrated multivariate approach to drug product and process development Int. J. Pharm. 382 2009 23 32
-
(2009)
Int. J. Pharm.
, vol.382
, pp. 23-32
-
-
Huang, J.1
Kaul, G.2
Cai, C.3
Chatlapalli, R.4
Abad, P.H.5
Ghosh, K.6
Nagi, A.7
-
28
-
-
0025235454
-
Secondary ion mass spectrometry (SIMS) evaluation of magnesium stearate distribution and its effects on the physico-technical properties of sodium chloride tablets
-
DOI 10.1016/0032-5910(90)80102-5
-
M.S.H. Hussain, P. York, P. Timmins, and P. Humphrey Secondary ion mass spectrometry (SIMS) evaluation of magnesium stearate distribution and its effects on the physico-technical properties of sodium chloride tablets Powder Technol. 60 1990 39 45 (Pubitemid 20645395)
-
(1990)
Powder Technology
, vol.60
, Issue.1
, pp. 39-45
-
-
Hussain, M.S.H.1
York, P.2
Timmins, P.3
Humphrey, P.4
-
30
-
-
78649332620
-
-
November Guideline Q7A: good manufacturing practices for active pharmaceutical ingredients
-
ICH harmonised tripartite guideline, November 2000. Guideline Q7A: good manufacturing practices for active pharmaceutical ingredients.
-
(2000)
ICH Harmonised Tripartite Guideline
-
-
-
31
-
-
12244293715
-
-
June Pharmaceutical quality systems Q10
-
ICH harmonised tripartite guideline, June 2008. Pharmaceutical quality systems Q10.
-
(2008)
ICH Harmonised Tripartite Guideline
-
-
-
34
-
-
53849130980
-
Quality by design: Concepts for ANDAs
-
R.A. Lionberger, S.L. Lee, L. Lee, A. Raw, and L.X. Yu Quality by design: concepts for ANDAs AAPS J. 10 2008 268 276
-
(2008)
AAPS J.
, vol.10
, pp. 268-276
-
-
Lionberger, R.A.1
Lee, S.L.2
Lee, L.3
Raw, A.4
Yu, L.X.5
-
35
-
-
36048950677
-
Novel description of a design space for fluidised bed granulation
-
DOI 10.1016/j.ijpharm.2007.05.051, PII S0378517307004747
-
T. Lipsanen, O. Antikainen, H. Räikkönen, S. Airaksinen, and J. Yliruusi Novel description of a design pace for fluidised bed granulation Int. J. Pharm. 345 2007 101 107 (Pubitemid 350087547)
-
(2007)
International Journal of Pharmaceutics
, vol.345
, Issue.1-2
, pp. 101-107
-
-
Lipsanen, T.1
Antikainen, O.2
Raikkonen, H.3
Airaksinen, S.4
Yliruusi, J.5
-
37
-
-
0001131698
-
The design of optimum multifactorial experiments
-
R.L. Plackett, and J.P. Burman The design of optimum multifactorial experiments Biometrika 33 1946 305
-
(1946)
Biometrika
, vol.33
, pp. 305
-
-
Plackett, R.L.1
Burman, J.P.2
-
40
-
-
84856514443
-
Generic drug approval process: Pre-1984 history concerning generic drugs
-
I.R. Berry, Marcel Dekker New York
-
D.L. Rosen Generic drug approval process: pre-1984 history concerning generic drugs I.R. Berry, The Pharmaceutical Regulatory Process 2005 Marcel Dekker New York 99 106
-
(2005)
The Pharmaceutical Regulatory Process
, pp. 99-106
-
-
Rosen, D.L.1
-
41
-
-
0003005657
-
A survey of current industrial practices in the formulation and manufacture of tablets and capsules
-
R.F. Shangraw, and D.A. Demarest A survey of current industrial practices in the formulation and manufacture of tablets and capsules Pharm. Technol. 17 1993 32 44
-
(1993)
Pharm. Technol.
, vol.17
, pp. 32-44
-
-
Shangraw, R.F.1
Demarest, D.A.2
-
42
-
-
0003796215
-
-
US Food and Drug Administration/US Department of agriculture Adopted August 14, 1997. (accessed on July 28, 2011)
-
US Food and Drug Administration/US Department of agriculture. Hazard analysis and critical control point principles and application guidelines. Adopted August 14, 1997. http://www.fda.gov/Food/FoodSafety/ HazardAnalysisCriticalControlPointsHACCP/HACCPPrinciplesApplicationGuidelines/ default.htm#guide (accessed on July 28, 2011).
-
Hazard Analysis and Critical Control Point Principles and Application Guidelines
-
-
-
43
-
-
84856525898
-
-
U.S. Pharmacopeial Convention, Inc., 2007. 12601 Twinbrook Parkway, Rockville, MD 20852, p. 25
-
U.S. Pharmacopeial Convention, Inc., 2007. 12601 Twinbrook Parkway, Rockville, MD 20852, p. 25.
-
-
-
-
44
-
-
4644224760
-
-
Voltarol" (accessed on December 6, 2011)
-
"Voltarol", Summary of product characteristics, 2011. http://www.medicines.org.uk/EMC/medicine/1340/SPC/ Voltarol+Dispersible+Tablets+50mg/ (accessed on December 6, 2011).
-
(2011)
Summary of Product Characteristics
-
-
|