Elliot Brown Consulting and Ergomed CRO have launched PrimeVigilance, a new pharmacovigilance services company. Founded by two globally respected experts, the newly formed PrimeVigilance Ltd. provides a unique offering in the field of pharmacovigilance, more here...
Dr Brown's Publications
Properties of transplantation antigen present in cell-free extracts of adenovirus 12 induced tumours in CBA mice. Brown EG, Potter C, Oxford J. Eur J Cancer 1969
A customised game as an aid for medical representative training. Brown EG, Brown L, Stevens D. In: The focus for pharmaceutical knowledge. Burley D, Haward C, Mullinger B eds. Macmillan Press 1988, 293-300.
Patient information leaflets from pharmaceutical companies: a survey of leaflets submitted to the Department of Health Brown EG. Pharmaceutical Medicine 1989, 4: 123-129.
Patient Information Leaflets: a progress report. Brown EG. BIRA Journal. 1989: 8(2),16-17
An overview of UK regulatory experience with patient information leaflets. Brown EG in Patient Information in Medicine. Mann R Ed, Parthenon Publishing 1990, 107-114
The interface between the medical profession and the pharmaceutical industry. Brown EG in Drug Safety, a shared responsibility. Churchill Livingstone 1991, 57-66
Safety profile of lacidipine: a reiew of clinical data. Endersby CE, Brown EG, Perelman MS. J Cardiovasc Pharmacol 1991 17 (Suppl 4) S45-S48
The safety and tolerability of sumatriptan: an overview. Brown EG, Endersby CA, Smith RN, Talbot JCC. Eur.Neurol. 1991: 31, 339-344
Product Information. Brown EG in A Textbook of Pharmaceutical Medicine. Mann RD, Rawlins MD, Auty RM Eds. Parthenon 1993, 295-308
Pharmacovigilance and the new regulatory process in Europe: a pharmaceutical industry benchmarking survey. Brown E. Pharmaceutical Medicine 1995, 9: 21-32
Evaluation of MEDDRA in representing medicinal product data sheet information. Brown EG, Clark E. Pharm Med 1996 10, 111-118
Medical terminology: a view from Europe. Brown EG. In Proceedings of the Third International Conference on Harmonisation d'Arcy PFD, Harron DWG Eds Queens University Belfast Publications 1996, 500-503
A comparison of two medical terminologies in coding and analysing clinical trial safety data. Brown DR, Brown EG, Moulvad TB. Int J Pharm Med 1997 11, 85-89
The Medical Dictionary for Regulatory Activities (MedDRA): a survey of regulatory authorities' approaches to implementation. Brown EG, David M. Int.J.Pharm.Med 1998.
ADR of the Month: tiaprofenic acid and interstitial cystitis. Brown EG, Waller PC, Sallie B. Postgrad Med. 1998
The safety of medicines in children. Brown EG, Choonara I. Int.J.Pharm.Med. 1998 12, 285-288.
Oral contraceptives and breast cancer. Current Problems in Pharmacovigilance 1998 24
A new reporting initiative for paediatric adverse drug reactions in the Trent region. Current Problems in Pharmacovigilance 1999, 25
In focus: donepezil (Aricept). Current Problems in Pharmacovigilance. 1999, 25
Update of guidance on SPC. SPC Coordinators Group. . Int.J.Pharm.Med, 1999 13, 35-42
The Medical Dictionary for Regulatory Activities (MedDRA).
Brown EG, Wood KL, Wood SM. Leading Article. Drug Safety, 1999 20 (2), 109-117
Coding of data – MedDRA and other medical terminologies. Brown EG and Wood L. In Clinical Data Management, Eds Rondel RK, Varley SA, Webb CF. Wiley. 2000
MedDRA, the Medical Dictionary for Regulatory Activities. Brown EG. In Clinical Research Manual. Euromed Communications. Supplement, 2000
Tabulation and analysis of pharmacovigilance data using the Medical Dictionary for Regulatory Activities. Brown EG, Douglas S, Pharmacoepidemiology and Drug Safety, 2000, 9; 479-501
Anyone here speak MedDRisch? Brown EG. Clinical Researcher.2000, 1, 46-54
MedDRA: an update. Brown EG. Industrial Pharmacist. 2001, 21, 5-7
Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART. Brown EG. Drug Safety 2002, 25(6), 445-452.
Methods and Pitfalls in Searching Drug Safety Databases Utilising the Medical Dictionary for Regulatory Activities (MedDRA). Leading article. Drug Safety 2003, 26(3):145-58.
Dictionaries and coding in pharmacovigilance. Brown EG. In: Detection of New Adverse Drug Reactions. 5th Edition. Stephens MDB, Talbot JCC, Routledge PA Editors. 2004
Introducing Triage Logic as a New Strategy for the Detection of Signals in the WHO Drug Monitoring Database. Stahl M, Lindquist M, Edwards IR, Brown EG. Pharmacoepidemiol Drug Saf. 2004 Jun;13(6):355-63.
Using MedDRA: implications for risk management. Brown EG. Drug Saf. 2004;27(8):591-602.
Data Monitoring Committees in Paediatric Research. van den Ouweland F, Brown EG, Carr DJ. Submitted for publication, 2004
UK guidelines on pharmacovigilance - Commentary. Int.J Pharm Med 1995 9,5-6.
Pharmacoepidemiology and Pharmacovigilance - Commentary. Int J Pharm Med 1997 11, 248
MEDDRA: setting a new standard in medical terminology - Editorial. Int J Pharm Med 1997 11, 189-190
Periodic Safety Update Reports: periodic curse or safety cursor? Editorial. Int.J.Pharm.Med 1998.
Points to consider about MedDRA – Commentary. Int J Pharm Med 2000 14, 200
New rules on pharmacovigilance in Europe: more of the same? Editorial. Int J Pharm Med 2002 16, 3-5
A comparison of the efficacy and cost of vancomycin versus teicoplanin in the treatment of CVC associated sepsis. Catchpole CR, Hastings JGM, Elliott TSJ, Brown EG. EAACI Annual conference, 1995
Evaluation of MEDDRA, a new medical regulatory terminology, in representing medicinal product data sheet information. Brown EG, Clark E. ISPE Annual Conference, Amsterdam, August 1996.
Use of a large spontaneous reporting database to validate suspected differences in reporting of vaginal bleeding as an adverse reaction between types of Hormone Replacement Therapies. Taherazadeh M, Davis S, Brown E. 15th International Conference on Pharmacoepidemiology, 1999.
A MedDRA pharmacovigilance database. Brown EG, Douglas S. 8th Annual meeting, European Society of Pharmacovigilance. Verona. September, 2000
The effect of different strategies of signal finding in WHO International ADR data. M. Lindquist, I. Ralph Edwards, M. Ståhl, E. Brown, M. Pettersson, A. Bate, A. Kiuru. ISOP annual conference, Tunis, September 2001
System requirements for searches of safety data using medical dictionary for regulatory activities. Brown EG, Pallet D. DIA Euromeeting, Basel, March 2002
Preparing for pharmacovigilance audit in the European Union: a practical guide. Brown EG. International Society of Pharmacovigilance annual conference, Amsterdam, October 2002
Dr. Goldman's Publications
Goldman SA. Communication of medical product risk: how effective is effective enough? Drug Safety 2004; 27(8): 519-534
Goldman SA. Postmarketing surveillance and black box warnings [letter]. JAMA 2002;288:956-957
Goldman SA. Adverse event reporting and standardized medical terminologies: strengths and limitations. Drug Info J 2002;36:439-444
Kennedy DL, Goldman SA, Lillie RB. Spontaneous reporting in the United States. In Strom B, ed. Pharmacoepidemiology. 3rd ed. West Sussex, England: John Wiley & Sons, Ltd, 2000:151-174
Goldman SA. Use of a mail-out continuing education article to teach health professionals about drug-induced disease. J Clin Pharmacol 1999;39:1126-1135
Starr C (Goldman SA: Article Consultant). Minimizing the risks of drug interactions. Patient Care 1999;33(6):26-68
Goldman SA. Limitations and strengths of spontaneous reports data. Clinical Therapeutics 1998; 20(Suppl C):C40-C44
Goldman SA, Kennedy DL. medWatch: FDA's medical products reporting program: a joint effort toward improved public health. Postgrad Med 1998;103:13-16
Kennedy DL, Goldman SA. Monitoring for adverse drug events. Am Fam Physician 1997; 56:1718-1721
Goldman SA. Drug-induced psychiatric disease [abstract]. International Pharmaceutical Abstracts 1996;33:2272
Goldman SA. Lithium and neuroleptics in combination: is there enhancement of neurotoxicity leading to permanent sequelae? J Clin Pharmacol 1996;36:951-962
Goldman SA. The clinical impact of adverse event reporting. medWatch continuing education article. Rockville, MD: Food and Drug Administration, October 1996. Available @ www.fda.gov/medwatch/articles.htm
Goldman SA. Lithium and neuroleptics in combination: the spectrum of neurotoxicity. Psychopharmacol Bull 1996;32:299-309
Goldman SA. Lithium and neuroleptics in combination: the spectrum of neurotoxicity. [accepted abstract for the Annual Meeting of the American College of Clinical Pharmacology, Philadelphia, PA, September 1996]. J Clin Pharmacol 1996;36:850
Goldman SA. MedWatch/CDER labeling summary will tell health care community what we know. News Along The Pike 1996;2:1-2
Goldman SA, Lieberman R, Kausal DJ. Teaching healthcare professionals about drug-induced disease: an innovative clinical therapeutic approach. J Clin Pharmacol 1996;36:386-396
Goldman SA, Lieberman R, Kausal DJ. Teaching health care professionals about drug-induced disease: an innovative clinical therapeutic approach [accepted abstract for the Annual Meeting of the American College of Clinical Pharmacology, Rockville, MD, September 1995]. J Clin Pharmacol 1995;35:940
Goldman SA. Lithium and neuroleptics in combination: is there enhancement of neurotoxicity leading to permanent sequelae? [accepted abstracts for the 1995 American Psychiatric Association and *New Clinical Drug Evaluation Unit (NCDEU) Annual Meetings]. *Psychopharmacol Bull 1995;31:574
Goldman SA, Kennedy DL, Lieberman R, eds. Clinical therapeutics and the recognition of drug-induced disease. medWatch continuing education article. Rockville, MD: Food and Drug Administration, June 1995. Available @ www.fda.gov/medwatch/articles.htm
Psychiatric Research Report (an APA Office of Research publication), Vol. 10, Winter 1995: article entitled "Inside The Food and Drug Administration" based upon original referenced manuscript by SA Goldman
Goldman SA. Awareness and utilization of cancer/AIDS auxiliary services at a university hospital [abstract, submitted to Academy of Psychosomatic Medicine for Annual Meeting, 1992]
Goldman SA. Organic delusional disorder on a consultation-liaison psychiatry service: report and review. Psychosomatics 1992;33:343-352
Goldman SA. Concerns and issues of the diagnostic category of organic mental disorders in the DSM-IV [letter]. Psychosomatics 1991;32:112
Goldman SA. Psychiatric aspects of chronic abdominal pain. MEDLINK 1990;Fall: 4 [Interview]
Goldman SA. Book review of Brain Imaging: Applications in Psychiatry. Andreasen, NC, ed. Washington, DC: American Psychiatric Press, 1989; Psychosomatics 1989;30:457-458
Goldman SA. Psychiatric consultation indicated for confused elderly hospitalized patients. MEDLINK 1989;Fall:3 [Interview]
Goldman SA, Arbuthnot J. Teaching medical ethics: the cognitive-developmental approach. J Med Ethics 1979;5:170-181
Elliot Brown Consulting Ltd
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