CLINICAL PHARMACOLOGY PDF
Basic & Clinical. Pharmacology. Edited by. Bertram G. Katzung, MD, PhD. Professor Emeritus. Department of Cellular & Molecular Pharmacology. University of. pharmacology in European medical schools -WHO. Working Group on Clinical Pharmacology in Europe. Clinical pharmacology and primary health care in. journal Basic and clinical Pharmacology and toxicology (BcPt) in , Volume , pages – this ecogenenergy.info (last accessed april.
|Language:||English, Spanish, French|
|ePub File Size:||19.86 MB|
|PDF File Size:||10.37 MB|
|Distribution:||Free* [*Regsitration Required]|
Clinical Pharmacology. Therapeutics: choosing the right drug and dose for the patient. Clinical Toxicology: identifying poisons in clinical and forensic cases. Professor of Clinical Pharmacology at King's College London School of Medicine , The fifth edition of A Textbook of Clinical Pharmacology and Therapeutics is. Clinical Pharmacology. Disease Progress and Drug Action. Nick Holford. Dept Pharmacology and Clinical Pharmacology. University of Auckland. Slide 2.
This has thus led to a debate between industry and the drug regulator with the clinial pharmacologist as an interested observer and participant of the value of what has become known as surrogate markers of efficacy.
A surrogate marker is defined as an accurate indicator of disease progression that does not rely on clinical findings. Such markers are used with varying degrees of confidence throughout clinical medicine and in drug development. For example, blood pressure is widely accepted as a surrogate for stroke and myocardial infarction. Tumour enlargement is used as a surrogate for the effect of anticancer treatment, even though it may not predict survival.
Intraocular pressure measurement is used as a clear surrogate for the clinical consequences of glaucoma. Bone density is used as a surrogate for the development of osteoporotic fractures, and for the assessment of drugs which influence osteoporosis. For a surrogate to be used as the sole end point of measurement of efficacy for regulatory purposes, it must exhibit a high degree of robustness.
Clinical pharmacology becomes a specialty in South Africa.
In each of the instances cited above, a good correlation has been shown to exist between the surrogate and an accepted clinical end point. Regulatory approval of a drug based on an inappropriate surrogate may lead to many patients receiving ineffective or even harmful therapy.
A therapeutic area where this debate has been most pointed is in the treatment of HIV disease.
The UK licensing authority has been more reluctant than its American or European counterparts to grant licences for anti HIV drugs unless the agent had shown significant changes in clinical end points such as difference in survival, progression to an AIDS defining clinical event or reduction in the incidence of opportunistic infection. Industry wishes to speed up the licence approval process by submitting surrogate data such as changes in CD4 count, or in viral load, i. In this context it is worthwhile remembering that the ideal surrogate marker should a be biologically plausible, b be detectable in most subjects at all stages of the disease, c show changes towards normal when an effective agent is given, d predict the ultimate clinical response in patients taking the drug, e discriminate between patients who will do well and those who will do badly.
In HIV disease, intense debate continues as to the value of the various surrogate markers and which conform to these five criteria. As ever, drug regulation must follow science, and science has not yet made up its mind on this issue.
Safety Adverse reactions to drugs range from effects on a single physiological control system to multiple organ failure, and their severity can vary from the apparently trivial to the rapidly fatal. Clinical pharmacology is concerned with risk assessment in drug therapy and as the science of toxicology develops, new classifications of adverse reactions emerge.
As with considerations of efficacy, regulation of drug safety must follow this scientific progress.
Clinical and biochemical pharmacology has shown that these infrequent but extremely dangerous Type B reactions may be due to either parent drug or to a toxicologically reactive metabolite. Where an imbalance occurs between the formation of such a metabolite and its detoxification, toxicity may result.
Materials for High Temperature Power Generation and Process Plant Applications
If the reactive metabolite binds covalently to essential macromolecules, or to DNA, or acts as a hapten, tissue damage may occur and clinical toxicity ensues. Factors influencing individual susceptibility to these idosyncratic forms of drug toxicity are poorly understood, but probably include genetic, metabolic and immunological factors.
With respect to those idiosyncratic reactions mediated via a hapten causing immune mediated toxicity, it may even be difficult to distinguish the effect of the immune response from that of the direct toxicity of the reactive metabolite.
Drugs of all classes may cause such reactions and they pose great problems for the pharmacologist and the regulator. Among the twenty two drugs whose licences were withdrawn for safety reasons over the past twenty years, idiosyncratic toxicity such as anaphylaxis, hepatotoxicity and haemolytic anaemia are frequently the basis for the regulatory decision.
Only by understanding the biochemical and chemical basis of these effects can drug design be improved to minimise drug toxicity.
Safety evaluation in drug regulation depends on three strategies—the control of quality, rigorous premarketing safety studies and post marketing surveillance. Quality is controlled in relation to both manufacture and wholesale selling and only one licensed drug penbutolol has been withdrawn from the UK market over the past twenty years because of quality problems. Premarketing safety evaluation is based on evidence from both preclinical and clinical studies. This book presents information on drugs, which junior doctors and students are most likely to encounter on hospital wards or during their course of study.
Written to provide a study aid or as a user friendly reference on the wards, the book gives you: An essential learning tool for clinical pharmacology A system based approach A-Z of key drugs in a one-drug-per-page format Important interactions, adverse effects and contraindications A fully indexed text A quick reference, pocket-sized reassurance This book will help take the stress out of clinical pharmacology and pharmacology exams!
Journal list menu
Reviews "a dinky ward reference Free Access. Summary PDF Request permissions. Tools Get online access For authors.
Email or Customer ID. Forgot password? Old Password. New Password. Your password has been changed.
Supplemental Nutrition Assistance Program: Examining the Evidence to Define Benefit Adequacy
Returning user. Request Username Can't sign in?Factors influencing individual susceptibility to these idosyncratic forms of drug toxicity are poorly understood, but probably include genetic, metabolic and immunological factors. We conclude with recommendations on how to ensure a healthy future for the discipline. Easily filter and sort the report by key clinical factors such as severity, incidence and onset.
These two statements set the stage for the discipline of Clinical Pharmacology CP which pursues two main goals: 1 an empirical description of conditions under which drug actions vary in humans and 2 to determine and understand the molecular mechanisms underlying this variability . Only by understanding the biochemical and chemical basis of these effects can drug design be improved to minimise drug toxicity.
Clinical Pharmacology and Therapeutics About the specialty: Training in Clinical Pharmacology and Therapeutics CPT is defined in the specialty training curriculum and is usually combined with training in General Internal Medicine and other dual specialty training programmes are possible.
In this context it is worthwhile remembering that the ideal surrogate marker should a be biologically plausible, b be detectable in most subjects at all stages of the disease, c show changes towards normal when an effective agent is given, d predict the ultimate clinical response in patients taking the drug, e discriminate between patients who will do well and those who will do badly.
Clinical Pharmacology & Therapeutics
The core functions of a clinical pharmacologist Drug policy formulation and implementation A major function of clinical pharmacologists is the promotion of the rational use of medicines. Unique to Clinical Pharmacology, optionally check for interactions between drugs and other life-style factors such as diet, smoking, alcohol consumption and more.