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Chemistry, Manufacturing, and Control

Chemistry, Manufacturing, and Control


Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells. Chemotherapy is used along with surgery, radiation therapy, or biological therapy. It works by stopping or slowing the rapidly growing cancer cells. However, chemotherapy can also harm healthy cells that divide quickly, such as those that line the mouth and intestines. Due to the effect these medicines have on healthy cells, serious or severe side effects are common.

Chronic Condition

A chronic condition is a long-lasting disease that can be controlled but not cured. The term chronic is usually applied when the course of the disease lasts for more than three months.

Common chronic diseases include asthma, chronic obstructive pulmonary disease (COPD), cancer, and diabetes. In certain diseases or conditions, prevention is effective in reducing the possible development of the condition or its effect. Early diagnosis and timely treatment can help to reduce serious effects of the condition.

Class effect

Class effect refers to the similar outcomes, therapeutic effects and similar adverse effects of two or more medicines. All products within a class are assumed to be closely related in three concepts: a similar chemical structure, mechanism of action, and pharmacological effects.

Classification of a medicinal product

In the EU there are two classifications of medicinal products for human use:
  1. medicinal products subject to medical prescription
  2. medicinal products not subject to medical prescription

Further subcategories may exist on a national level.


Clearance is a term in pharmacokinetics which describes the volume of plasma that is completely cleared of a substance per unit time. The usual units are mL/min. The total body clearance will be equal to the renal (kidney) clearance + hepatic (liver) clearance + lung clearance although for many medicines the clearance is simply considered as the renal excretion ability.

Clinical development

Clinical development is one step in the process of bringing new medicines or treatments to the market. Based on non-clinical research (microorganisms/animals), it refers to clinical trials, which are done in people. They follow different phases designated as Phase I, II, III (and IV after marketing authorisation).

Clinical effectiveness

As a component of a dossier submitted for HTA assessment, clinical effectiveness is a measure of how well a particular treatment works in the practice of medicine. It depends on the application of the best knowledge derived from research, clinical experience, and patient preferences.

Clinical efficacy

In medicine, clinical efficacy indicates a positive therapeutic effect. If efficacy is established, an intervention is likely to be at least as good as other available interventions to which it will have been compared. When talking in terms of efficacy versus effectiveness, efficacy measures how well a treatment works in clinical trials or laboratory studies. Effectiveness, on the other hand, relates to how well a treatment works in the practice of medicine.

Clinical pharmacology

In relation to clinical development, pharmacology deals with the effects of compounds (medicines in development) in healthy volunteers and in patients. It usually includes pharmacodynamics and pharmacokinetics. In the evaluation process the action and adverse effects of compounds can be measured and compared.

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