-
1
-
-
84875479150
-
-
Confederation of Indian Industry. Background paper. Conference on Clinical research: Roadmap for India, New Delhi: Sep 2003, 24-25, [Last accessed on 2012 Jul 07]
-
Confederation of Indian Industry. Background paper. Conference on Clinical research: Roadmap for India, New Delhi: Sep 2003, 24-25. Available from: http://www.icriindia.com/pdf/conference-on-clinical-research-road-map-for- india.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
2
-
-
84875424568
-
-
U.S. Government Printing Office. Code of Federal Regulation Part 46.102(d), [Last accessed on 2012 Jul 07]
-
U.S. Government Printing Office. Code of Federal Regulation, Part 46. 102(d). Available from: http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr & sid=40b8414de2b96f123d892712afc06258&rgn=div5 & view=text and node=45:1.0.1.1.25 & idno=45#45:1.0.1.1.25.1.1.2. [Last accessed on 2012 Jul 07].
-
-
-
-
3
-
-
34250887722
-
M R.Clinical trials in India
-
Maiti R, M R.Clinical trials in India. Pharmacol Res 2007;56:1-10.
-
(2007)
Pharmacol Res
, vol.56
, pp. 1-10
-
-
Maiti, R.1
-
4
-
-
84875447494
-
-
RNCOS [Internet]. Booming Clinical Trials Market In India Aug 2011, [Last accessed on 2012 Jul 07]
-
RNCOS [Internet]. Booming Clinical Trials Market in India, Aug 2011, Available from: http://www.rncos.com/Report/IM564.htm. [Last accessed on 2012 Jul 07].
-
-
-
-
5
-
-
84875417833
-
-
Modern Medicine (Home page), Jun 1 2004, [Last accessed on 2012 Aug 17]
-
Modern Medicine (Home page). Lamberti MJ, Space S, Gammbrill S. Going global. Jun 1 2004. Available from: http://www.modernmedicine.com/ modernmedicine/article/articleDetail.jsp?id=98387. [Last accessed on 2012 Aug 17].
-
Going Global
-
-
Lamberti, M.J.1
Space, S.2
Gammbrill, S.3
-
6
-
-
84875436443
-
-
Applied Clinical Trials (Home Page), 2011 Aug 01, [Last accessed on 2012 Aug 17]
-
Applied Clinical Trials (Home page). Wechsler J. FDA seeks new approach to global challenges. 2011 Aug 01. Available from: http://www. appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp? id=734368. [Last accessed on 2012 Aug 17].
-
FDA Seeks New Approach to Global Challenges
-
-
Wechsler, J.1
-
7
-
-
84875436748
-
-
[Last accessed on 2012 Jul 04]
-
Jayasheel BG. Carrying out clinical trials in India. Available from: http://www.acunovalife.com/pdf/whitepapers/RAJ-Pharma%20June%202010- Jayasheel%20final.pdf. [Last accessed on 2012 Jul 04].
-
Carrying Out Clinical Trials in India
-
-
Jayasheel, B.G.1
-
8
-
-
84875412217
-
-
Federations of Indian chambers of commerce and industry; the Glorious metamorphosis: Compelling reasons for doing clinical research in India, Sep 2009, [Last accessed on 2012 Jul 07]
-
Federations of Indian chambers of commerce and industry; the Glorious metamorphosis: Compelling reasons for doing clinical research in India, Sep 2009. Available from: http://www.ficci.com/publication-page.asp?spid=20026. [Last accessed on 2012 Jul 07].
-
-
-
-
9
-
-
48149101847
-
-
Social Sector: Volume II; Planning Commission, Government of India, New Delhi: Oxford University Press
-
Social Sector: Volume II; Planning Commission, Government of India. Eleventh Five Year Plan (2007-2012). New Delhi: Oxford University Press; 2008.
-
(2008)
Eleventh Five Year Plan (2007-2012)
-
-
-
10
-
-
48749112420
-
Clinical trials in India: Ethical concerns
-
Chatterjee P. Clinical trials in India: Ethical concerns. Bull World Health Organ 2008;86:581-2.
-
(2008)
Bull World Health Organ
, vol.86
, pp. 581-582
-
-
Chatterjee, P.1
-
11
-
-
55549106653
-
-
[Last accessed on 2008 Mar 06]
-
Varma S. India a hobted for clinical trials. Available from: http://www.timesofindia.indiatimes.com/articleshow/1776215.cms. [Last accessed on 2008 Mar 06].
-
India A Hobted for Clinical Trials
-
-
Varma, S.1
-
12
-
-
36949039439
-
Bio-business in brief: The challenges of clinical trials
-
Mehdiratta R, Parida DK, Saberwal G. Bio-business in brief: The challenges of clinical trials. Curr Sci 2007;93:1367-75.
-
(2007)
Curr Sci
, vol.93
, pp. 1367-1375
-
-
Mehdiratta, R.1
Parida, D.K.2
Saberwal, G.3
-
13
-
-
84875411885
-
-
[Last accessed on 2012 Jul 20]
-
Sinha K. India Overtakes china as a no.1 destination for clinical trials. Available from: http://www.timesofindia.indiatimes.com/India-overtakes-China- as-no1-destination-for-clinical-trials/articleshow/2927126.cms. [Last accessed on 2012 Jul 20].
-
India Overtakes China As A No.1 Destination for Clinical Trials
-
-
Sinha, K.1
-
14
-
-
84886388352
-
How to minimize low enrolling sites: A case study in diabetes
-
Abraham A, Jones J, Vikram S. How to minimize low enrolling sites: A case study in diabetes. Perspect Clin Res 2010;1:25-8.
-
(2010)
Perspect Clin Res
, vol.1
, pp. 25-28
-
-
Abraham, A.1
Jones, J.2
Vikram, S.3
-
15
-
-
84886426113
-
Quality of independent review boardethics committee oversight in clinical trials in india
-
Pandiya A. Quality of Independent review board/ethics committee oversight in clinical trials in India. Perspect Clin Res 2011;2:45-7.
-
(2011)
Perspect Clin Res
, vol.2
, pp. 45-47
-
-
Pandiya, A.1
-
16
-
-
0035183126
-
Guidelines for Good Clinical Practice E6
-
ICH harmonized tripartite guidelines, [Last accessed on 2012 Jul 24]
-
ICH harmonized tripartite guidelines. Guidelines for Good Clinical Practice E6. J Postgrad Med [serial online] 2001;47:45-50. Available from: http://www.jpgmonlins.com/text.asp?2001/47/1/45/235. [Last accessed on 2012 Jul 24].
-
(2001)
J Postgrad Med [Serial Online]
, vol.47
, pp. 45-50
-
-
-
17
-
-
80054901528
-
Integrated monitoring: Setting new standards for the next decade of clinical trial practice
-
Rai K. Integrated monitoring: Setting new standards for the next decade of clinical trial practice. Perspect Clin Res 2011;2:28-33.
-
(2011)
Perspect Clin Res
, vol.2
, pp. 28-33
-
-
Rai, K.1
-
18
-
-
79551603686
-
The health of European medical research. Attempts are under way to update EU regulations, with the aim of harmonizing clinical research across the continent
-
Hunter P. The health of European medical research. Attempts are under way to update EU regulations, with the aim of harmonizing clinical research across the continent. EMBO Rep 2011;12:110-2.
-
(2011)
EMBO Rep
, vol.12
, pp. 110-112
-
-
Hunter, P.1
-
19
-
-
33645694087
-
Ethical and Legal issue in research involving human subjects: Do you want a piece of me
-
Kapp MB. Ethical and Legal issue in research involving human subjects: Do you want a piece of me. J Clin Pathol 2006;59:335-9.
-
(2006)
J Clin Pathol
, vol.59
, pp. 335-339
-
-
Kapp, M.B.1
-
20
-
-
84886376719
-
Indian clinical trials: Paradigm shift from speed to quality?
-
Bhatt A. Indian clinical trials: Paradigm shift from speed to quality? Perspect Clin Res 2012;3:1-3.
-
(2012)
Perspect Clin Res
, vol.3
, pp. 1-3
-
-
Bhatt, A.1
-
21
-
-
84875433650
-
-
Pharmaceutical Policy-2002. Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, [Last accessed on 2012 Aug 17]
-
Pharmaceutical Policy-2002. Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals. Available from: http://www. chemicals.nic.in/pharma4.htm. [Last accessed on 2012 Aug 17].
-
-
-
-
22
-
-
84886393860
-
Sir Ram Nath Chopra: A profile
-
Singh H. Sir Ram Nath Chopra: A profile. J Young Pharm 2009;1:192-4.
-
(2009)
J Young Pharm
, vol.1
, pp. 192-194
-
-
Singh, H.1
-
23
-
-
84875476425
-
-
The Drug and Cosmetic Act, 1940 and The Drugs and Cosmetic Rules, 1945 as amended time to time. Ministry of Health and Family Welfare, Government of India, [Last accesseed on 2012 Jul 10]
-
The Drug and Cosmetic Act, 1940 and The Drugs and Cosmetic Rules, 1945 as amended time to time. Ministry of Health and Family Welfare, Government of India. Available from: http://www.cdsco.nic.in/Drugs&CosmeticAct.pdf. [Last accesseed on 2012 Jul 10].
-
-
-
-
24
-
-
84875452837
-
-
Central Drugs Standards Control organization. Ministry of Health and Family Welfare, [Last accessed on 2012 Jul 04]
-
Central Drugs Standards Control organization. Ministry of Health and Family Welfare. Available from: http://cdsco.nic.in/html/organisationalchart. htm. [Last accessed on 2012 Jul 04].
-
-
-
-
25
-
-
84875472240
-
-
MedIndia (Home page). Drugs and cosmetics act, 1940-The drug consultative committee, [Last accessed on 2012 Aug 18]
-
MedIndia (Home page). Drugs and cosmetics act, 1940-The drug consultative committee. Available from: http://www.medindia.net/indian-health-act/drugs-and- cosmetics-act-1940-the-drugs-consultative-committee.htm. [Last accessed on 2012 Aug 18].
-
-
-
-
26
-
-
33645406928
-
A costly prescription
-
Narrain S. A costly prescription. Frontline 2005;22:12-25.
-
(2005)
Frontline
, vol.22
, pp. 12-25
-
-
Narrain, S.1
-
27
-
-
77951798997
-
Indian Patent Law in the post-TRIPS Decade: S and T Policy Appraisal
-
Damodaran AD. Indian Patent Law in the post-TRIPS Decade: S and T Policy Appraisal. J Intellect Prop Rights 2008;13:414-23.
-
(2008)
J. Intellect Prop Rights
, vol.13
, pp. 414-423
-
-
Damodaran, A.D.1
-
28
-
-
60249102390
-
A detailed study of patent system for protection of inventions
-
Tulasi GK, Rao BS. A detailed study of patent system for protection of inventions. Indian J Pharm Sci 2008;70:547-54.
-
(2008)
Indian J Pharm Sci
, vol.70
, pp. 547-554
-
-
Tulasi, G.K.1
Rao, B.S.2
-
29
-
-
84886412875
-
Intellectual property rights: An overview and implications in pharmaceutical industry
-
Saha CN, Bhattacharya S. Intellectual property rights: An overview and implications in pharmaceutical industry. J Adv Pharm Technol Res 2011;2:88-93.
-
(2011)
J Adv Pharm Technol Res
, vol.2
, pp. 88-93
-
-
Saha, C.N.1
Bhattacharya, S.2
-
30
-
-
0029183617
-
The GATT TRIPS Agreement and health care in India
-
Otten A. The GATT TRIPS Agreement and health care in India. Natl Med J India 1995;8:1-3.
-
(1995)
Natl Med J India
, vol.8
, pp. 1-3
-
-
Otten, A.1
-
33
-
-
84875479937
-
-
Health Group Criticizes India's New Drug Patent Law, [Last accessed on 2012 Jul 07], on 27-03-2005
-
Health Group Criticizes India's New Drug Patent Law. Available from: http://www.Scitech-today.com/story.html? Story-id=31764 on 27-03-2005. [Last accessed on 2012 Jul 07].
-
-
-
-
34
-
-
84875450235
-
-
20 January 2005, New Delhi, [Last accessed on 2012 Jul 07]
-
Amended Schedule Y [Drug and Cosmetic act (2 nd amendment) rules]. 20 January 2005, New Delhi. Available from: http://www.cdsco.nic.in/html/ scheduleY%20(Amended%20Version2005)%20original.htm. [Last accessed on 2012 Jul 07].
-
Amended Schedule Y [Drug and Cosmetic act (2 nd amendment) rules]
-
-
-
37
-
-
17244367345
-
A new colonialism-Conducting clinical trials in India
-
Nundy S, Gulhati CM. A new colonialism-Conducting clinical trials in India. N Engl J Med 2005;352:1633-6.
-
(2005)
N Engl J Med
, vol.352
, pp. 1633-1636
-
-
Nundy, S.1
Gulhati, C.M.2
-
38
-
-
55549089312
-
Clinical Research in India: Great expectations
-
Thatte UM, Bavdeka SB. Clinical Research in India: Great expectations. J Postgrad Med 2008;54:318-23.
-
(2008)
J Postgrad Med
, vol.54
, pp. 318-323
-
-
Thatte, U.M.1
Bavdeka, S.B.2
-
39
-
-
77951843284
-
Foreign firms drive surge in tech patents, trend reflects the more complex R and D work being done in India, MNCs outpace local peers
-
June
-
Viswanath K. Foreign firms drive surge in tech patents, trend reflects the more complex R and D work being done in India, MNCs outpace local peers. Live Mint, 2008 June 9.
-
(2008)
Live Mint
, vol.9
-
-
Viswanath, K.1
-
40
-
-
84875411362
-
-
Central Drug Standard Control Organization. Targeted Timelines for Approvals of Complete Applications by DCG(I) office, [Last accessed on 2012 Jul 07]
-
Central Drug Standard Control Organization. Targeted Timelines for Approvals of Complete Applications by DCG(I) office. Available from: http://www.cdsco.nic.in/revised-new-timelines.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
41
-
-
84886408336
-
Regulatory consideration for conducting clinical trials in India
-
Kumar M, Kher S. Regulatory consideration for conducting clinical trials in India. Regul Aff Focus 2007;12:26-31.
-
(2007)
Regul Aff Focus
, vol.12
, pp. 26-31
-
-
Kumar, M.1
Kher, S.2
-
42
-
-
84875465296
-
Practical aspects of conducting clinical trials in India
-
[Last accessed on 2012 Sept 19]
-
Kumar M. Practical aspects of conducting clinical trials in India. Regul Focus 2009;30-7. Available from: http://www.amarexcro.com/articles/docs/RAPS- Focus-Practical-Feb2009.pdf. [Last accessed on 2012 Sept 19].
-
(2009)
Regul Focus
, pp. 30-37
-
-
Kumar, M.1
-
43
-
-
84865455735
-
Trials and tribulations of clinical research teaching and training
-
Ghooi RB. Trials and tribulations of clinical research teaching and training. Perspect Clin Res 2010;1:139-42.
-
(2010)
Perspect Clin Res
, vol.1
, pp. 139-142
-
-
Ghooi, R.B.1
-
44
-
-
42149089872
-
Pharmaceutical GMP: Past, Present and Future-A review
-
Patel KT, Chotai NP. Pharmaceutical GMP: Past, Present and Future-A review. Pharmazie 2008;63:251-5.
-
(2008)
Pharmazie
, vol.63
, pp. 251-255
-
-
Patel, K.T.1
Chotai, N.P.2
-
45
-
-
0037241067
-
Good clinical practice: A nuisance, a help or a necessity for clinical pharmacology?
-
Sweatman J. Good clinical practice: A nuisance, a help or a necessity for clinical pharmacology? Br J Clin Pharmacol 2003;55:1-5.
-
(2003)
Br J Clin Pharmacol
, vol.55
, pp. 1-5
-
-
Sweatman, J.1
-
46
-
-
77957273053
-
Good laboratory practices
-
Selvakumar R. Good laboratory practices. Indian J Clin Biochem 2010;25:221-4.
-
(2010)
Indian J Clin Biochem
, vol.25
, pp. 221-224
-
-
Selvakumar, R.1
-
47
-
-
36749084524
-
Guidelines on good clinical laboratory practices
-
Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, Hitchcock R, et al. Guidelines on good clinical laboratory practices. J Pharm Biomed Anal 2008;46:18-29.
-
(2008)
J Pharm Biomed Anal
, vol.46
, pp. 18-29
-
-
Ezzelle, J.1
Rodriguez-Chavez, I.R.2
Darden, J.M.3
Stirewalt, M.4
Kunwar, N.5
Hitchcock, R.6
-
48
-
-
84875467292
-
-
Guiding Document For Zonal And Sub Zonal, [Last accessed on 2012 Jul 07]
-
Guiding document for zonal and sub zonal. Available from: http://www.cdsco.nic.in/Guidance-doc-fuct-cdsco-subzonal/ guidingdocumentsforzona and subzonal&portoffices 17.06.2011.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
50
-
-
84875478397
-
-
Drug Policy 2002, [Last accessed on 2012 Jul 07]
-
Drug Policy 2002. Available from: http://www.dbtbiosafety.nic.in/Files/ CD-IBSC/Fi-Les/2002.PDF. [Last accessed on 2012 Jul 07].
-
-
-
-
51
-
-
84875414718
-
-
Drug (Price Control) Order 1995, [Last accessed on 2012 Jul 07]
-
Drug (Price Control) Order 1995. Available from: http://www.nppaindia. nic.in/drugprice95/txt.html. [Last accessed on 2012 Jul 07].
-
-
-
-
52
-
-
84875455423
-
-
Pharmaceutical Policy. Feb 15, 2002, [Last accessed on 2012 Jul 07]
-
Pharmaceutical policy. Feb 15, 2002. Available from: http://www. nppaindia.nic.in/May2002/policy02.html. [Last accessed on 2012 Jul 07].
-
-
-
-
53
-
-
84875422754
-
-
Department Of Biotechnology Ministry Of Science And Technology, [Last accessed on 2012 Jul 07]
-
Department of Biotechnology, Ministry of Science and Technology. Available from: http://www.dbtindia.nic.in/index.asp. [Last accessed on 2012 Jul 07].
-
-
-
-
54
-
-
84875429971
-
-
Atomic Energy Regulatory Board, [Last accessed on 2012 Jul 07]
-
Atomic Energy Regulatory Board. Available from: http://www.aerb.gov.in. [Last accessed on 2012 Jul 07].
-
-
-
-
55
-
-
84875466319
-
-
Bhabha Atomic Research Centre. Government Of India Department Of Atomic Energy, [Last accessed on 2012 Jul 07]
-
Bhabha Atomic Research Centre. Government of India, department of Atomic energy. Available from: http://www.barc.ernet.in. [Last accessed on 2012 Jul 07].
-
-
-
-
56
-
-
84875455652
-
-
Ministry Of Health And Family Welfare, [Last accessed on 2012 Jul 07]
-
Ministry of Health and Family Welfare. Available from: http://www.mohfw.nic.in. [Last accessed on 2012 Jul 07].
-
-
-
-
57
-
-
84875477887
-
-
Department Of Chemicals And Petrochemicals (home Page) Ministry Of Chemicals And Fertilizers, [Last accessed on 2012 Jul 07]
-
Department of Chemicals and Petrochemicals (home page), Ministry of Chemicals and Fertilizers. Available from: http://chemicals.nic.in. [Last accessed on 2012 Jul 07].
-
-
-
-
58
-
-
84875419399
-
-
Ministry Of Environment And Forest (home Page), [Last accessed on 2012 Jul 07]
-
Ministry of Environment and Forest (home page). Available from: http://www.moef.nic.in/index.php. [Last accessed on 2012 Jul 07].
-
-
-
-
59
-
-
84875440863
-
-
Ministry Of Finance (Home Page), [Last accessed on 2012 Jul 07]
-
Ministry of Finance (Home page). Available from: http://www.finmin.nic. in. [Last accessed on 2012 Jul 07].
-
-
-
-
60
-
-
84875455178
-
-
Department Of Industrial Policy And Promotion Ministry Of Commerce And Industry, [Last accessed on 2012 Jul 07]
-
Department of Industrial Policy and Promotion, Ministry of Commerce and industry. Available from: http://dipp.nic.in/English/default.aspx. [Last accessed on 2012 Jul 07].
-
-
-
-
61
-
-
84875444542
-
-
Department Of Science And Technology Ministry Of Science And Technology, [Last accessed on 2012 Jul 07]
-
Department of science and technology, ministry of science and technology. Available from: http://www.dst.gov.in. [Last accessed on 2012 Jul 07].
-
-
-
-
62
-
-
84875427664
-
-
Directorate General Of Foreign Trade Ministry Of Commerce And Industry, [Last accessed on 2012 Jul 07]
-
Directorate general of foreign Trade, Ministry of Commerce and Industry. Available from: http://dgft.gov.in. [Last accessed on 2012 Jul 07].
-
-
-
-
63
-
-
84875410406
-
-
The Poison Act 1919, [Last accessed on 2012 Jul 07]
-
The Poison Act, 1919. Available from: http://www.indiankanoon.org/doc/ 1399304. [Last accessed on 2012 Jul 07].
-
-
-
-
64
-
-
84875415564
-
-
The Pharmacy Act 1948, [Last accessed on 2012 Jul 07]
-
The Pharmacy Act, 1948. Available from: http://www.gujhealth.gov.in/ images/pdf/legis/pharmacy-act-1948.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
65
-
-
84875462049
-
-
The Drugs And Magic (Objectionble Advertising) Act 1954, [Last accessed on 2012 Jul 07]
-
The Drugs and Magic (Objectionble Advertising) Act, 1954. Available from: http://www.rfhha.org/images/pdf/Hospital-Laws/Drugs-Magic-remedies- (%20advertisement)-act.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
66
-
-
84875466327
-
-
The Narcotic Drugs And Psychotropic Substances Act 1985, [Last accessed on 2012 Jul 07]
-
The Narcotic Drugs and Psychotropic Substances Act, 1985. Available from: http://www.dor.gov.in/sites/upload-files/revenue/files/pdf/NDPS-Act-1985-as- amended.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
67
-
-
84875428735
-
-
The Insecticides Act 1968, [Last accessed on 2012 Jul 07]
-
The Insecticides Act, 1968. Available from: http://www.cibric.nic.in/ Insecticides-act.htm. [Last accessed on 2012 Jul 07].
-
-
-
-
68
-
-
84875423276
-
-
The Medicinal And Toilet Preparation Act 1985, [Last accessed on 2012 Jul 07]
-
The Medicinal and Toilet preparation Act, 1985. Available from: http://www.dor.gov.in/medicinalandtoilet act. [Last accessed on 2012 Jul 07].
-
-
-
-
69
-
-
84875458842
-
-
The Drug (Price Control) Order 1995, [Last accessed on 2012 Jul 07]
-
The Drug (Price Control) Order, 1995. Available from: http://www.nppaindia.nic.in/drugprice95/txt1.html. [Last accessed on 2012 Jul 07].
-
-
-
-
70
-
-
84875471513
-
-
The Industries (Development And Regulation) Act 1951, [Last accessed on 2012 Jul 07]
-
The Industries (Development and Regulation) Act, 1951. Available from: http://www.dipp.nic.in/English/policies/Industries-act1951.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
71
-
-
84875415495
-
-
The Trade And Merchandise Act 1958, [Last accessed on 2012 Jul 07]
-
The Trade and Merchandise Act, 1958. Available from: http://www.indiaip. com/in-dia/trademarks/acts/tmact1958.htm. [Last accessed on 2012 Jul 07].
-
-
-
-
72
-
-
84875414821
-
-
The Indian Patent Act 1970, [Last accessed on 2012 Jul 07]
-
The Indian Patent Act, 1970. Available from: http://www.spicyip.com/docs/ statutecombined%20patents%20act%202005.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
73
-
-
84875425578
-
-
The Design Act 2000, [Last accessed on 2012 Jul 07]
-
The Design Act, 2000. Available from: http://www.ipindia.nic.in/ipr/ design/design-act.PDF. [Last accessed on 2012 Jul 07].
-
-
-
-
74
-
-
84875443595
-
-
The Factories Act 1948 (Amended on 1987), [Last accessed on 2012 Jul 07]
-
The Factories Act, 1948 (Amended on 1987). Available from: http://www.nihfw.nic.in/ndcnihfw/html/Legislations/The Factories Act 1948.htm. [Last accessed on 2012 Jul 07].
-
-
-
-
75
-
-
84860425403
-
A stinging indictment of india's drug regulatory authority
-
Srinivasan S. A stinging indictment of india's Drug regulatory Authority. Economic and Political weekly 2012;47:10-3.
-
(2012)
Economic and Political Weekly
, vol.47
, pp. 10-13
-
-
Srinivasan, S.1
-
76
-
-
84875460661
-
-
Guidelines On Approval Of Clinical Trials And New Drugs, [Last accessed on 2012 Jul 07]
-
Guidelines on approval of clinical trials and new drugs. Available from: http://www.cdsco.nic.in/Guidance-for-New-Drug-Approval.23.07.2011.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
77
-
-
84875468740
-
-
World Medical Association. Declaration of Helsinki, [Last accessed on 2012 Jul 07]
-
World Medical Association. Declaration of Helsinki. Available from: http://www.wma.net/epolicy. [Last accessed on 2012 Jul 07].
-
-
-
-
78
-
-
84875428487
-
-
CDSCO. Draft Guidance For Industry On Reporting Serious Adverse Events Occurring In Clinical Trials, [Last accessed on 2012 Jul 07]
-
CDSCO. Draft guidance for industry on reporting serious adverse events occurring in clinical trials. Available from: http://www.cdsco.nic.in/SAE%. 20GUIDELINES%2005-052011.pdf. [Last accessed on 2012 Jul 07].
-
-
-
-
79
-
-
84875420609
-
Post marketing surveillance
-
May 30, [Last accessed on 2012 Jul 07]
-
Francis PA. Post marketing surveillance. Pharmabiz.com. 2012, May 30. Available from: http://www.pharmabiz.com/ArticleDetails.aspx?aid=69273&sid= 3. [Last accessed on 2012 Jul 07].
-
(2012)
Pharmabiz.com.
-
-
Francis, P.A.1
-
80
-
-
41049108651
-
Registering clinical trials in India: A scientific and ethical imperative
-
Tharyan P, Ghesri D. Registering clinical trials in India: A scientific and ethical imperative. Natl Med J India 2008;21:31-4.
-
(2008)
Natl Med J India
, vol.21
, pp. 31-34
-
-
Tharyan, P.1
Ghesri, D.2
-
81
-
-
84875425335
-
-
CDSCO, Ministry of Health and Family Welfare, Government of India 2010. Nov [Last accessed on 2012 Jul 07]
-
Pharmacovigilance programme of India 2010. CDSCO, Ministry of Health and Family Welfare, Government of India. 2010. Nov. Available from: http://www.cdsco.nic.in/pharmacovigilance-intro.htm. [Last accessed on 2012 Jul 07].
-
Pharmacovigilance Programme of India 2010
-
-
-
82
-
-
84875464168
-
-
Indian Pharmacopoeias Commission. NCC Pharmacovigilance Programme Of India, [Last accessed on 2012 Jul 07]
-
Indian Pharmacopoeias Commission. NCC Pharmacovigilance programme of India. Available from: http://www.ipc.gov.in/index1.asp?linkid=222. [Last accessed on 2012 Jul 07].
-
-
-
-
85
-
-
78650631190
-
Drug trials in children: Doubts and dilemmas
-
Dalvi B. Drug trials in children: Doubts and dilemmas. Ann Pediatr Cardiol 2008;1:81-2.
-
(2008)
Ann Pediatr Cardiol
, vol.1
, pp. 81-82
-
-
Dalvi, B.1
|