Routes of administration

The pharmacokinetics of benzo[a]pyrene have been studied among mice differing at a single genetic locus (Neb t, 1981). The studies 

POLYCYCLIC HYDROCARBON 4b-INDUCTION OF P,-450 t ib-TUMORS. TOXICITY. orroxiCATiON W TUMORS. TOXICITY 

POLYCYCLIC HYDROCARBON INDUCTION OF P,-450 TUMORS, TOXICITY DETOXICATION 4b- TUMORS. TOXICITY 

It should be emphasized, however, that this relationship for genetically determined enzyme toxicity has been worked out in detail only with polycyclic hydrocarbon carcinogens. It remains to be determined how many other classes of carcinogens may also show such differences. 

In contrast to penetrating radiation, which passes through tissue in a weU-known manner, or even with the more complex situations arising fiom nonuniform distributions of internally deposited radionuclides, dosimetry of chemicals is far more difficult. Factors requiring consider ation in chemical dosimetry include the type of chemical under consideration, dose, duration of exposure, route of administration, aU possible metabolic pathways, capacity of the chemical to affect its own metabolism, pharmacokinetics, rate of excretion, and dose to the biological target at sites of tumor formation (which may vary depending on the route of administration). 

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ControUed release pharmaceuticals provide local or systemic treatment and differ in design depending on thek use and route of administration. The potential sites for controUed dehvery of therapeutic agents and some of the systems designed for those sites merit discussion. 

LD50 The ealeulated dose of ehemieal (mg per kg body weight) eausing death in 50% of test population. (The speeies of animal, route of administration, any vehiele used to dissolve or suspend the material, and the time period of exposure should be reported.)... 

Polycyclic aromatic hydrocarbons have been classified as human carcinogens because they induce cancers in experimental animals and because smoking and exposure to mixtures of chemicals containing polycyclic aromatic hydrocarbons in the workplace increase the risk of lung cancer in exposed individuals. In experimental animals, benzo(a)pyrene induces cancer in different organs depending on the route of administration.Furthermore, exposure to polycyclic aromatic hydrocarbons commonly occurs in occupations related to traffic (use of diesel engines in transportation and railways). 

Area under the Curve (AUC) refers to the area under the curve in a plasma concentration-time curve. It is directly proportional to the amount of drug which has appeared in the blood ( central compartment ), irrespective of the route of administration and the rate at which the drug enters. The bioavailability of an orally administered drug can be determined by comparing the AUCs following oral and intravenous administration. 

Like penicillins, cephalosporins are (3-lactam antibiotics and interfere with bacterial cell wall synthesis. A very large number of cephalosporins are available for clinical use. They differ in their route of administration and clinical use. 

Certain factors may influence drug response and are considered when the primary health care provider prescribes and the nurse administers a drug. These factors include age, weight, gender, disease, and route of administration. 

The major use of the narcotic analgesic is to relieve or manage moderate to severe acute and chronic pain. The ability of a narcotic analgesic to relieve pain depends on several factors, such as the drug, the dose, the route of administration, the type of pain, the patient, and the length of time the drug has been administered. Morphine is the most widely used opioid and an effective drug for... 

If theophylline or anotiier xanthine derivative is given as a rectal suppository, the nurse checks die patient every 15 to 30 minutes to be sure die suppository has been retained. If the patient is unable to retain die suppository, die nurse contacts the primary health care provider because anodier route of administration may be necessary. 

Other adverse reactions include local irritation when heparin is given via the SC route. Hypersensitivity reactions may also occur with any route of administration and include fever, chills, and urticaria. More serious hypersensitivity reactions include an astiima-like reaction and an anaphylactoid reaction. 

The expected outcomes of the patient depend on the specific drug, dose, route of administration, and reason for administration of an electrolyte but may include an... 

Name and description of the investigational product(s). A summary of findings from non-clinical sfudies and from clinioal trials that is relevant to the trial. Summary of the known and potential risks and benefits, if any, to human subjects. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). Description of the population to be studied. References to literature and data that are relevant to the trial, and that provide background for the trial... 

This module should contain data from all of the non-dinical studies conducted to investigate the pharmacological and toxicological properties of the dmg substance/ product. The standard headings used to present this information are shown in Figure 6.4. Study reports should be presented in the following order according to species and route of administration ... 

Type of Study Study Location of Objective(s) Identifier Study Report of the Study Study Design and Type of Control Test Product(s) Dosage Regimen Route of Administration Number of Subjects Healthy Subjects or Diagnosis of Patients Duration of Treatment Study Status Type of Report... 

Marketing Extension Application (change in active substance, bioavailability, pharmacokinetics, strength, pharmaceutical form or route of administration, if... 

Strength, form route of administration, container and pack sizes... 

Changes to strength, pharmaceutical form or route of administration. 

Compound Animals Route of administration Number of doses Range of doses [mg/kg]... 

As discussed earlier, selectivity is the consequence of the interplay between toxicokinetic and toxicodynamic factors. Some examples are given in Table 2.8, which will now be briefly discussed (data from Walker and Oesch 1983, and Walker 1994a,b). These and other examples will be described in more detail under specific pollutants later in the text. In the table, comparisons are made between the median lethal doses or concentrations for different species or strains. Comparisons are made of data obtained in lethal toxicity tests where the same route of administration was used for species or strains that are compared. The degree of selectivity is expressed... 

In this section the intraperitoneal route of liposome administration will be discussed. For a number of diseases this route of administration may be preferred over the intravenous route of administration of liposomes. For example, intraperitoneal injection of drug-... 

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