People In Life Sciences (P.I.L.S.)
Articles appear twice a month,
exploring the complex issues and strategies driving global
compliance in all areas of the pharmaceutical industry. Read all
The Bitterest Pill
October 7, 2004
Merck suffered a huge blow
last week when it announced the largest voluntary drug recall in
history after a study confirmed that rofecoxib (marketed as VIOXX,
) raises the risk of heart attack and stroke. While it may be
tempting to simply take two aspirin and hope the pain of the VIOXX
withdrawal will go away, now is the time for us all to review our
role in the drug development process.
Show us your data
September 23, 2004
It has become clear that pharmaceutical companies
are going to have to publicly register their clinical trials and
be more forthcoming with the results – both good and bad! With
around 350 registries already in existence, where, when and how
will this data appear?
September 13, 2004
It’s hard to turn on the TV or look at a magazine
these days without seeing an advertisement extolling the virtues
of some new wonder drug and challenging you to ask your doctor
if the drug is right for you.
Mergers and acquisitions: Do they add up?
August 23, 2004
At nearly every major merger announcement,
executives state that laboratory synergies and the need to
strengthen product portfolios by plugging pipeline gaps are
major driving forces behind the deals.
Study Data Tabulation Model: Striving toward a
standard clinical data format
August 9, 2004
There is mounting concern in the industry that
basic research is not resulting in safe and affordable products
reaching patients quickly enough.
Statins: The highs and lows of cholesterol-lowering
July 20, 2004
Federal health officials have released updated
guidelines on cholesterol management advising physicians to
consider new, more intensive treatment options for people at
high and moderately high risk for a heart attack.
Six Sigma: Just another quality system?
July 8, 2004
Quality systems are not new to the pharmaceutical
industry and most companies will be familiar with cGXP and ISO
9000. However, before dismissing Six Sigma as just another
quality system, and throwing all that promotional literature
away, remember that Six Sigma is a set of continual improvement
FDA guidance: three-part series
June 21, 2004
The third of the new FDA guidance documents,
entitled Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment, focuses specifically on
post-marketing risk assessment.
June 7, 2004
This issue of the P.I.L.S. Compliance Column
concentrates on the second of the recently issued draft guidance
documents, Development and Use of Risk Minimization Action
Plans and discusses its significance for the compliance
May 17, 2004
This issue of the P.I.L.S. Compliance Column
explores “Premarketing Risk Assessment” and FDA recommendations
to maximize the information gained from clinical trials.
A risky approach
May 3, 2004
FDA identified efficient risk management as the
primary way to make the most effective use of resources and
address the challenges of public-health protection.
Checklists: Compliance or
April 19, 2004
The pharmaceutical industry is among the most
heavily regulated -- and rightly so.
The road to regulatory compliance
April 5, 2004
It is perhaps most appropriate to begin at the
beginning and explain the origins of modern-day regulation in
A Reed Elsevier Publication
Good Clinical Practice Journal
Brookwood Medical Publications
Pharmacoeconomics & Outcome News
Trials and tribulations - clinical trials and the road to new
arthritis medicines (pdf)
An overview of the problems associated with viral gene delivery
(BTi Nov 1999 Volume 11, No. 5)
Has Gene Therapy
A follow-up article to "Viral Gene Delivery"
(BTi June 2002 Volume 14, No. 3)
Country Focus: France. Neighbors but a World Apart - Biotechnology in Alsace and
(BTi Jan 2000 Volume 11, No.
Size Matters -
an interview with Philip Ledger, PHARMITRA
(GCPj Vol. 6 No. 5, September/October 1999)
challenges of clinical trials in cancer
(GCPj Vol. 6 No. 4, July/August 1999)
really like statistics?
(GCPj Vol. 6 May/June 1999)
Over the counter
(GCPj Vol. 5 November/December 1998)
(CGPj Vol. 5 September/October 1998)
Clinical Practice - Standard Operating Procedures for Clinical Researchers
of biopharmaceutics classification system and in vitro-in vivo correlation in
the approval of drug products
Accelerating proof of
concept - rapidly progressing to therapeutic studies
Streamlining Phase I/IIa Trials
Role of oxaliplatin in
(4 March 2000, No. 1227)
Gene therapy: promising in
(18 March 2000, No. 1229)
improves QOL in cancer-related anaemia
(26 Feb 2000, No. 251)
Secondary upper limb lymphoedema: the QOL impact for women
(25 March 2000, No. 255)
inpatient care for children's acute lymphoblastic leukaemia
(1 April 2000, No. 256)
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