Pharmacology Volume 4

The effects on our Phase I work HMR is a contract clinical pharmacology unit have been interesting and, perhaps, unexpected.

• Les Fourberies de Scapin (Théâtre de Molière) (French Edition)!
• VOLUME 4 - ISSUE 2 - CLINICAL PHARMACOLOGY IN THE HEADLINES: REFLECTIONS ON THE TGN1412 TRIAL?
• Methodik der Traumdeutung: mit Symbollexikon (German Edition)?
• Runaway?

For example, more volunteers have come forward: Our volunteers now ask more questions about safety, and more of them withdraw between screening visit and first dosing day. But nervousness at the time of dosing has not increased, nor has our drop-out rate changed from its usual very low level.

Both of the ethics committees that review our projects seem understandably more nervous than before, and have queried the arrangements for compensation of injured subjects. Remarkably, neither our sponsors nor we at HMR, at least have changed our routine procedures for first-in-human studies of conventional pharmaceuticals.

In particular, we continue to dose subjects in cohorts of 8—10, and at intervals of 5—10 minutes. The media coverage of the events was, in my view, of a high standard. We received many requests for interviews, and we granted as many as we could do without compromising our work.

It is disappointing that no physician from Parexel made a statement of any kind; that presumably reflects company policy but I feel that this was a serious mistake. Should we now change the way that we develop mAB as medicines? The TGN disaster has shown, in the most harrowing manner, what we feared — that animal toxicology predicts poorly what mAB will do in humans. Moreover, the occurrence of six life-threatening adverse reactions means that the safety record of mAB in healthy volunteers is now poor — perhaps even unacceptable.

But the truth is that we cannot be certain that we can predict similarly serious acute toxicity of another mAB in future. Moreover, there is justified concern over potential long-term adverse effects of mAB: But the immunologists in Wurzburg University, the scientists at TeGenero, the MHRA assessors, the Parexel physicians, and the ethics committee all failed to predict it. So, on whose advice can we rely when we decide whether to give an mAB to healthy volunteers or not?

Anuka , Isa M. Hussaini , Abdulkadir U. Zezi , Bilkisu B. Maiha and Malami Sani.

Contact Information

Gupta Atyam and N. Rajalakshmi , Edel Priya and P. Abdul , Siddig I.

Abdelwahab , Adel S. Gana , Brian R. Alfredo Coviello , Marcelo O. Soria , Maria C. Proto , Dora M. Berman , Silvia S. Gamundi , Claudia E.

Alonso , Adolfo J. Ma , David O. Denis Richard , Serge Rivest.

Canadian Journal of Physiology and Pharmacology. Select All For Selected Content: Role of cGMP in relaxation of vascular and other smooth muscle. Effects of manganese chloride, verapamil, and hypoxia on the rate-dependent increase in internal longitudinal resistance of rabbit myocardium. Mechanisms underlying the cardiovascular responses to intrathecal vasopressin administration in rats.

Some pharmacological activities of novel adenine-related compounds isolated from a marine sponge Agelas mauritiana.