Archive for the ‘Pharmacology’ Category

Bridging Studies – Company Culture and Structure of a CRO for conducting Bridging Studies

Monday, October 28th, 2013

The merits of a CRO (Clinical or Contract Research Organisation) with regards to subject retention and recruitment should be evaluated with at least similar attention and care as is given to a CRO’s ability to conduct a bridging study clinically and produce good quality viable data. When selecting a CRO or recruitment specialist to recruit specialist subject populations such as Japanese subjects, a sponsor will need to take into account various factors, including:

  • Company structure and culture
  • Safety record
  • Track record
  • Approaches to recruitment such as advertising, attraction and retention
  • Safeguard against over-volunteering

Company Culture and Structure

The appropriate company culture and infrastructure is very important to both subjects and sponsors who are considering participating in a bridging study, especially for the first time. A good CRO understands this and is able to ensure that their staff is trained appropriately such that they can deal with various populations. Their staff should also be able to understand small but sometimes very important nuances that demonstrate that the CRO is able to successfully integrate within the target population. A company that is involved in conducting clinical trials that involve Japanese subjects can only be taken seriously if they place the appropriate amount of significance on bridging the cultural gap.

The clinical trial environment subjects are entering is naturally foreign to them, especially if this is the first trial they have made a decision to participate in. Such an environment can be even more daunting for Japanese subjects, and it is therefore imperative that the CRO ensures a cultural blend within its employees, which will enable it to meet its volunteer’s needs. This blend must be evident through the entire company, originating from the first point of contact (within the marketing branch) that a potential Japanese subject has with the CRO, through to its interaction with clinical staff and subject recruitment agents.

A good way of easing initial concerns that a Japanese subject may have about becoming involved in bridging studies (clinical research) is by ensuring that the company has a core group of well-trained professional Japanese employees. The presence of such employees in all facets of the company serves as extended infrastructure to the Japanese subjects and helps to cement the bond of trust that is necessary for success in specialist research.

When searching for a good indicator of how well a CRO has performed in appropriately integrating itself within the target recruitment population, you don’t have to look any further than their repeat rate of Japanese trial participants, along with the extent to which previous trial participants recommend friends and colleagues to participate in a trial with a CRO. This is easier to achieve with an inbuilt Japanese infrastructure within the CRO, as it serves as a demonstration to existing and potential Japanese clinical trial participants of the importance of these subjects to new drug development within the Japanese population demographic. Moreover, such an inbuilt culture and infrastructure, when combined with the trust that must be worked on continuously, routinely translates into a CRO on which sponsors can confidently depend.

One such Clinical Research Organisation based in the United Kingdom is Richmond Pharmacology who has conducted over 50 successful bridging studies on Japanese and Caucasian subjects. If you would like to learn more about bridging studies, please visit www.bridgingstudies.com

Five facts about birth control pills

Saturday, May 28th, 2011

Asking, in any case, always represents a healthy exercise. Often happens that, whether out of shame or by fear to leave in evidence our intellectual weaknesses, men restrict the questions, too bad, therefore while itself not the ignorance be asked will continue there in its place.

birth control pills

All about the pill
Especially in the case of health, it is always important to clear any unknown. Birth control pills serve as an example of the risk to be enclosed in a taboo one: there are few women, for misuses of them have suffered serious problems from pregnancy to some type of poisoning. Therefore, from here, we present five questions, and its answers, on, just the pill.

Are there any possibility of having infertility if treatment is stopped?
Impossible. The pills can leave at the time that you want and, among the factors that may occur, there is nothing like that. The chance of infertility due to abandonment of the drug is not covered by any such medication. (more…)

Keys of Chinese Medicine

Tuesday, November 9th, 2010

According to the principles of Chinese medicine, a poor flow of energy can jeopardize the body’s balance. Since the acupuncture, the Qi Gong, these therapeutic disciplines are intended to restore harmony within the energy flows.

In China, the medicine is transmitted from generation to generation. The greater the number of previous generations devoted to medicine, the greater the prestige and respect received. Chinese medicine has over 5000 years and is particularly interested in communicating different physiological functions.

Branches of knowledge
These are closely connected the each other through a flow of energy called “Chi”. This energy is the basis of Chinese medical principle. Under this principle, the disease is the result of a crash or some energetic imbalances. (more…)

Drug-receptor Interactions

Monday, May 10th, 2010

Few drugs, if any, have absolute specificity, but most features on selectivity, eg., Atropine inhibits the action of acetylcholine on smooth muscle and exocrine glands, but not the skeletal muscle. The selective action of these drugs is due to their physical-chemical bond with cellular components known as receptors. The receptors are physiological molecules involved in transmitting chemical signals between a cell and another and within cells. A molecule that binds to a receptor is defined ligand. When a ligand (hormone, neurotransmitter, drug or intracellular messenger exogenous) combines with a receptor cell function is changed, each ligand can interact with multiple receptor subtypes. The receptors activated directly or indirectly regulate cellular biochemical processes (eg., Ion conductance, protein phosphorylation, transcription of DNA). In many cases, the receptors located within the cell membrane are coupled through the guanine nucleotide binding proteins (G proteins) with different effector systems involving molecules that act as intracellular second messengers.

The receptors are dynamic structures, affected by both external factors and by intracellular regulatory mechanisms. The up-regulation and down-regulation of receptors relate phenomena of adaptation to drugs which have important clinical implications (desensitization, tolerance, acquired resistance, hypersensitivity to suspension).

The specific regions of macromolecules molecular receptor which binds the ligand recognition sites are called. A drug may interact at the same site which interacts with an endogenous agonist (hormone or neurotransmitter) or at a different site. Agonists that bind to adjacent sites or different allosteric agonists are sometimes called. The drugs are also linked in a non-specific, ie not at the molecular features of sites like receptors (eg., Plasma proteins). (more…)

General pharmacology

Tuesday, November 10th, 2009

Medication: Any substance or combination of substances for treating or preventing disease in human, as well as product out that can be administered to humans or animals to establish a diagnosis or to restoring, correcting or modify their functions.
Whatever its form combines a drug:
An active (therapeutic)
A vehicle (no action against the disease, support the active ingredient)
With an adjuvant (facilitates the implementation, administration, or retention of the drug).
The origins of drugs:
A plant (herbal)
Ä animal (opotherapy)
Ä mineral (trace element, mercury, …)
Ä microbial origin (antibiotics, vaccines, …)
Ä synthetic origin (chemotherapy, …)
Ä biotechnological origin (laboratory, biogenetic engineering, …). (more…)

Steroids

Tuesday, November 10th, 2009

Mechanisms of Action
Steroids alter the synthesis of proteins therefore alter:

  • Chemotaxis,
  • Metabolism
  • Expression (hormones, mediators).

Pharmacological Actions

Cortisol (hormone)
Corticosteroid (drug)
Anti-inflammatory effects,
Provide glucose to the brain,
Effects immuno-modulators,
Effects on carbohydrate
Effects on carbohydrate
Effects on lipids,
Effects on lipids,
Effects on protein
Effects on protein
Metabolic,
Effects on the brain
Cardiac effects.

(more…)

Find Health & Nursing Advices