Others
Nanospheres of Biodegradable Polymers: A System for Clinical Administration of an Anticancer Drug Paclitaxel (Taxol®)
Paclitaxel (Taxol®) is a diterpenoid extracted from the bark of a rare, slow growing Pacific yew or Western yew tree (Taxus brevifolia). Its antitumour activity was detected in 1967 in the US NCI (National Cancer Institute) screening of cytotoxic agents from natural products and was then found later to...
Others
Pharmacogenetics: Role in Modifying Drug Dosage Regimens
Synder in 1932 wrote the first report on the Mendelian inheritance of the inability to taste phenylthiourea. Twenty-five years later, Arno Motulsky suggested hereditary factors might be the explanation to inter-individual differences in drug responses.
This article is available only as a PDF. Please click on “Download PDF” on top...
Others
Post-Release Drug Treatment Risks: Strategies to Minimise Harm to Patients
Physicians have long accepted unreliable evaluations of the risks attached to pharmacotherapy, i.e. treating our patients with drugs. The reasons for the uncritical attitude towards medication, which comprise 60% to 90% of all clinical interventions, depending on specialty, have not been systematically studied.
This article is available only as a...
Others
Clinical Drug Evaluation: The Regulatory Perspectives
Evaluating new drugs for marketing approval is a highly specialised and knowledge-intensive activity. This is especially so if the intention is to conduct quality, safety and clinical evaluations of new drugs that have not been approved elsewhere.
This article is available only as a PDF. Please click on “Download PDF”...
Others
Meta-analyses of Clinical Drug Trials—Gold Standard Reviews or Statistical Alchemy?
Informal review and synthesis of scientific evidence has been practised for as long as experiments have been replicated. The idea of quantitatively combining the evidence from different samples can be traced back to the early 1900s, when Karl Pearson analysed the preventive effect of serum inoculations against enteric fever.
This...
Others
Megatrials of Drug Treatments: Strengths and Limitations
A “megatrial” is a very large randomised controlled clinical trial (RCT) recruiting many thousands of patients from many centres in order to assess the effectiveness of treatments on clinical outcomes. Examples of megatrials which successfully recruited more than 10,000 patients include the International Studies of Infarct Survival (ISIS) series...
Others
Clinical Drug Trials: Practical Problems of Phase III
There has been a rapid increase in clinical trial activity in Singapore and other parts of Asia. Randomised clinical trials are the “gold standard” in study design, which enable the question of efficacy of different treatments or managements to be effectively compared.
This article is available only as a PDF....
Others
Design of Phase I and II Clinical Trials in Oncology and Ethical Issues Involved
Drug development is costly and time-consuming in terms of economic, patient and research resources. An integrated effort involving academia, industry, and regulatory authorities is needed to ensure novel, effective therapies continue to be approved for clinical use.
This article is available only as a PDF. Please click on “Download PDF”...
Others
Clinical Drug Development—Practical Issues in Clinical Pharmacology Studies
Clinical pharmacology (CP) as a discipline comes in many guises. The perception for a medical student, and for many doctors, may be that of a painful series of lists of drugs to learn, the drugs being traditionally classified by functionality and effects.
This article is available only as a PDF....
Others
A Review of Software for Data Management, Design and Analysis of Clinical Trials
In clinical trials, subjects are usually entered one at a time, and their responses to treatment monitored sequentially. Regular monitoring of trial progress during the early stages is advisable, and prompt attention to data errors, inconsistencies or missing items on the case record forms (CRFs) is required, so that...
Others
Assessment of Patient Sociodemographic Variables in Clinical Trials—Can Patient Characteristics Make a Difference?
The pathway by which patients enter clinical trials can be a selective, non-random process. In order for patients to enter clinical trials, a set of circumstances must occur exclusive of having the disease being investigated and meeting clinical entry criteria.
This article is available only as a PDF. Please click...
Others
Estimation of Number of Subjects Required for Comparison of Drug versus Control in Adaptive Designs
Traditional designs for clinical trials make balanced (or 50-50) allocation of patients to treatments. This is done in the past to minimise the variance of different estimators.
This article is available only as a PDF. Please click on “Download PDF” on top to view the full article.
Others
The Ethics of Placebo-Controlled Trials in Developing Countries to Prevent Mother-to-Child Transmission of HIV
Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing ‘gold standard’ treatments like zidovudine.
This article is available only as a PDF. Please click...
Editorial
Evaluating Drugs from Cradle to Grave—Evolving Systems for a Complex Activity
Are medicines dangerous chemicals or life enhancing agents? The answer is ‘Both of those things, often at the same time, and worse in the wrong hands’.
This article is available only as a PDF. Please click on “Download PDF” on top to view the full article.