INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER
... validated (specificity, quantitation limit, detection limit, linearity, accuracy, repeatability, etc.) and that they are adequate to detect important deviations from the specifications. It can be considered to add a column with this information to the Tables 4 and 5 above. 2.1.P.5.4 ...
... validated (specificity, quantitation limit, detection limit, linearity, accuracy, repeatability, etc.) and that they are adequate to detect important deviations from the specifications. It can be considered to add a column with this information to the Tables 4 and 5 above. 2.1.P.5.4 ...
![Anti-malarial drugs [PPT]](http://s1.studyres.com/store/data/001023053_1-290b43cb3c1a88894829d7bbd7225c0f-300x300.png)
Anti-malarial drugs [PPT]
... Mechanism of action: • It is actively concentrated by sensitive intraerythrocytic plasmodia by accumulating in the acidic vesicles of the parasite and weakly basic nature it raises the vesicular pH and thereby interferes with degradation of haemoglobin by parasitic lysosomes • Polymerization of tox ...
... Mechanism of action: • It is actively concentrated by sensitive intraerythrocytic plasmodia by accumulating in the acidic vesicles of the parasite and weakly basic nature it raises the vesicular pH and thereby interferes with degradation of haemoglobin by parasitic lysosomes • Polymerization of tox ...
Triphala
... Triphala is a drug widely used in many disorders due to its various pharmacological activities. Triphala is composed of the three myrobalans, Terminalia chebula Retz. (Haritaki), Terminalia bellerica Roxb. (Bibhitaki) and Emblica officinalis Gaertn. (Amalaki) and is one of the most commonly used Ayu ...
... Triphala is a drug widely used in many disorders due to its various pharmacological activities. Triphala is composed of the three myrobalans, Terminalia chebula Retz. (Haritaki), Terminalia bellerica Roxb. (Bibhitaki) and Emblica officinalis Gaertn. (Amalaki) and is one of the most commonly used Ayu ...
Emerging Drug List SIBUTRAMINE
... activity for norepinephrine, serotonin, and to a lesser extent, dopamine. The precise mechanism by which sibutramine acts as an anorexiant is not known. However, sibutramine is believed to act by decreasing food/energy intake or increasing energy expenditure, or a combination of both. The recommende ...
... activity for norepinephrine, serotonin, and to a lesser extent, dopamine. The precise mechanism by which sibutramine acts as an anorexiant is not known. However, sibutramine is believed to act by decreasing food/energy intake or increasing energy expenditure, or a combination of both. The recommende ...
Missing Data: Turning Guidance into Action
... Recent research has fostered new guidance on preventing and treating missing data. This paper is the consensus opinion of the Drug Information Association’s Scientific Working Group on Missing Data. Common elements from recent guidance are distilled and means for putting the guidance into action are ...
... Recent research has fostered new guidance on preventing and treating missing data. This paper is the consensus opinion of the Drug Information Association’s Scientific Working Group on Missing Data. Common elements from recent guidance are distilled and means for putting the guidance into action are ...
... selecting patients with a high level of bronchial hyperresponsiveness, repeated deep inspiration, followed by forced expiration used for spirometry, may in itself produce bronchoconstriction. Both the terbutaline and placebo p-MDI formulations caused a similar transient fall in sGaw that reached a m ...
ICA-D-12-00158R1 Title: Cisplatin
... Gold-coated iron oxide nanoparticles with tethered platinum drug have been developed in an effort to produce a means of directing the movement and localisation of drugs in chemotherapy directly to the sites of solid tumours using external magnetic fields. ...
... Gold-coated iron oxide nanoparticles with tethered platinum drug have been developed in an effort to produce a means of directing the movement and localisation of drugs in chemotherapy directly to the sites of solid tumours using external magnetic fields. ...
- Wiley Online Library
... within a specific range of serum concentrations (henceforth called “reference range”) with lower concentrations being more likely to produce an insufficient effect, and higher concentrations being more often associated with adverse effects. Therapeutic drug concentration monitoring (TDM) was initiat ...
... within a specific range of serum concentrations (henceforth called “reference range”) with lower concentrations being more likely to produce an insufficient effect, and higher concentrations being more often associated with adverse effects. Therapeutic drug concentration monitoring (TDM) was initiat ...
Rifamycins and Cardiovascular Agents: Drug
... Increase BP monitoring; consider alternate lipid lowering agent to minimize effect; consider increasing statin dose; consider using Rifabutin in place of Rifampin. ...
... Increase BP monitoring; consider alternate lipid lowering agent to minimize effect; consider increasing statin dose; consider using Rifabutin in place of Rifampin. ...
EVALUATION OF PHYSICAL PROPERTIES OF JIT-TRA-ROM FAST DISINTEGRATING TABLETS
... Insomnia is usually treated by behavioral therapy and/or pharmacological therapy. Hypnotic drugs are also a popular treatment. They have a potent effect to decrease sleep onset and increase sleep duration, but they also have a lot of side effects, such as drug dependence, drug tolerance, anterograde ...
... Insomnia is usually treated by behavioral therapy and/or pharmacological therapy. Hypnotic drugs are also a popular treatment. They have a potent effect to decrease sleep onset and increase sleep duration, but they also have a lot of side effects, such as drug dependence, drug tolerance, anterograde ...
The Development of Context-specific Operant Sensitization to d
... If sensitization develops, then less of a drug is needed to produce the original effects of the drug. Tolerance has been shown to be one process involved in the development of drug addiction. Tolerance can result in more of a drug being needed to achieve the same initial effect. Tolerance can either ...
... If sensitization develops, then less of a drug is needed to produce the original effects of the drug. Tolerance has been shown to be one process involved in the development of drug addiction. Tolerance can result in more of a drug being needed to achieve the same initial effect. Tolerance can either ...
Cimetidine - Clemson University
... upon cimetidine because the drugs Zantac, Axid, and Pepcid have been developed. • These drugs are among the second generation of H2 antagonists that were introduced in the 1980’s. • These drugs use aromatic groups in place of the imidazole functionality. ...
... upon cimetidine because the drugs Zantac, Axid, and Pepcid have been developed. • These drugs are among the second generation of H2 antagonists that were introduced in the 1980’s. • These drugs use aromatic groups in place of the imidazole functionality. ...
Product Information Roar Ex Vivo CETP Activity
... influences the reverse cholesterol transport pathway. The Roar Ex Vivo CETP Activity Assay is a unique assay that eliminates the dilution factor associated with conventional CETP activity assays. The method is performed with all plasma components at near physiological concentration, measuring CETP a ...
... influences the reverse cholesterol transport pathway. The Roar Ex Vivo CETP Activity Assay is a unique assay that eliminates the dilution factor associated with conventional CETP activity assays. The method is performed with all plasma components at near physiological concentration, measuring CETP a ...
BASS & ULLMAN, I?G.
... bronchodilators was discussed in a recent article in the FDA’s own consumer publication, the FDA Consumer which was published after the 1995 proposal to reclassify ephedrine as a prescription drug: Both prescription and over-the-counter (OTC) short-acting bronchodilators are available. The OTC drugs ...
... bronchodilators was discussed in a recent article in the FDA’s own consumer publication, the FDA Consumer which was published after the 1995 proposal to reclassify ephedrine as a prescription drug: Both prescription and over-the-counter (OTC) short-acting bronchodilators are available. The OTC drugs ...
Clinical Pharmacokinetics Of
... Case #6: required to know the most appropirate method to adjust pharmcokinetic parameters if phenobarbital concentration = 29mg/L Case #7: required to know a revised plasma concentration, using anon-steady state continous infusion model Case #8: epileptic patient developed to hypoalbuminemia s ...
... Case #6: required to know the most appropirate method to adjust pharmcokinetic parameters if phenobarbital concentration = 29mg/L Case #7: required to know a revised plasma concentration, using anon-steady state continous infusion model Case #8: epileptic patient developed to hypoalbuminemia s ...
Validated RP-HPLC Method for Concurrent Determination of
... intra-day and intermediate variation. For these determinations, Repeatability studies were performed by analysis of three different concentrations of the drugs for six times on same day. The intermediate precision of the method was checked by repeating studies on three different days. Robustness The ...
... intra-day and intermediate variation. For these determinations, Repeatability studies were performed by analysis of three different concentrations of the drugs for six times on same day. The intermediate precision of the method was checked by repeating studies on three different days. Robustness The ...
Click here B. Pharmacy Syllabus
... Note: Examiner to set eight questions and the candidates are required to attempt any five. 1. Introduction: Definition, history, scope and development of Pharmacognosy. (2) 2. Sources of drugs: Biological, marine, geographical and plant tissue cultures. (4) 3. Classification of drugs: Alphabetical, ...
... Note: Examiner to set eight questions and the candidates are required to attempt any five. 1. Introduction: Definition, history, scope and development of Pharmacognosy. (2) 2. Sources of drugs: Biological, marine, geographical and plant tissue cultures. (4) 3. Classification of drugs: Alphabetical, ...
Simulated Biological Fluids with Possible Application in Dissolution
... Potential alternative portals of drug entry to the systemic circulation include buccal, sublingual, nasal, pulmonary, and vaginal routes, among others. These routes of administration are also used for the local delivery of drugs directly to the site of action, with consequent reduction in the dose n ...
... Potential alternative portals of drug entry to the systemic circulation include buccal, sublingual, nasal, pulmonary, and vaginal routes, among others. These routes of administration are also used for the local delivery of drugs directly to the site of action, with consequent reduction in the dose n ...
IN-SITU INJECTABLE THERMOSENSITIVE GEL BASED ON POLOXAMER AS A NEW... FOR TAMOXIFEN CITRATE
... solubility of the drug [9]. Although solubility enhancement of TMC may improve its bioavailability from oral dosage forms, the drug side effects cannot be reduced. Therefore, there was an urgent need for a new dosage form that can reduce TMC side effects through localizing its presence at cancerous ...
... solubility of the drug [9]. Although solubility enhancement of TMC may improve its bioavailability from oral dosage forms, the drug side effects cannot be reduced. Therefore, there was an urgent need for a new dosage form that can reduce TMC side effects through localizing its presence at cancerous ...
IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) e-ISSN: 2278-3008, p-ISSN:2319-7676.
... 2005. The annual number of AIDS deaths can be expected to increase for many years to come, unless more effective and patient compliant anti-retroviral medications are available at affordable prices [3]. The major drawbacks of antiretroviral drugs for the treatment of AIDS are their adverse side effe ...
... 2005. The annual number of AIDS deaths can be expected to increase for many years to come, unless more effective and patient compliant anti-retroviral medications are available at affordable prices [3]. The major drawbacks of antiretroviral drugs for the treatment of AIDS are their adverse side effe ...
IV-phenytoin-in-SE-version 3.1 final
... studies reviewed advocating lower rates of 25-40mg per minute. In conclusion, the authors of this review considered that rates of 50mg per minute were safe in young patients and a rate of 25mg per minute should be used in patients over 50 years. This because older patients have a higher risk of hypo ...
... studies reviewed advocating lower rates of 25-40mg per minute. In conclusion, the authors of this review considered that rates of 50mg per minute were safe in young patients and a rate of 25mg per minute should be used in patients over 50 years. This because older patients have a higher risk of hypo ...
Pharmacologic Treatment Options for Obesity: What Is Old Is New Again
... Information). These side effects are related to the constituents of PHEN/TPM ER or, in the case of constipation, to weight loss per se. Phentermine, as a sympathomimetic agent, causes insomnia and dry mouth, usually early in treatment, which then resolve. Topiramate is a carbonic anhydrase inhibitor ...
... Information). These side effects are related to the constituents of PHEN/TPM ER or, in the case of constipation, to weight loss per se. Phentermine, as a sympathomimetic agent, causes insomnia and dry mouth, usually early in treatment, which then resolve. Topiramate is a carbonic anhydrase inhibitor ...
here - Specialist Pharmacy Service
... studies reviewed advocating lower rates of 25-40mg per minute. In conclusion, the authors of this review considered that rates of 50mg per minute were safe in young patients and a rate of 25mg per minute should be used in patients over 50 years. This because older patients have a higher risk of hypo ...
... studies reviewed advocating lower rates of 25-40mg per minute. In conclusion, the authors of this review considered that rates of 50mg per minute were safe in young patients and a rate of 25mg per minute should be used in patients over 50 years. This because older patients have a higher risk of hypo ...
Amiglyde-V - zoetisUS.com
... endometrial biopsy tissue within one hour after infusion. Twenty-four hours after each treatment amikacin activity is still detectable at concentrations averaging 2 to 4 mcg/g. However, the drug is not appreciably absorbed systemically following intrauterine infusion. Endometrial tissue concentratio ...
... endometrial biopsy tissue within one hour after infusion. Twenty-four hours after each treatment amikacin activity is still detectable at concentrations averaging 2 to 4 mcg/g. However, the drug is not appreciably absorbed systemically following intrauterine infusion. Endometrial tissue concentratio ...
Determination of Atorvastatin Pharmacokinetic
... The CYP3A4 isoenzymes activity both in the intestine and in the liver is highly variable among individuals [24]. The bioavailability of Atorvastatin is low about (14%) [25, 26] and the drugs with low bioavailability are exposed to variation in drug plasma concentration. These facts may provide a rea ...
... The CYP3A4 isoenzymes activity both in the intestine and in the liver is highly variable among individuals [24]. The bioavailability of Atorvastatin is low about (14%) [25, 26] and the drugs with low bioavailability are exposed to variation in drug plasma concentration. These facts may provide a rea ...
Pharmacokinetics
Pharmacokinetics, sometimes abbreviated as PK (from Ancient Greek pharmakon ""drug"" and kinetikos ""moving, putting in motion""; see chemical kinetics), is a branch of pharmacology dedicated to determining the fate of substances administered externally to a living organism. The substances of interest include pharmaceutical agents, hormones, nutrients, and toxins. It attempts to discover the fate of a drug from the moment that it is administered up to the point at which it is completely eliminated from the body.Pharmacokinetics describes how the body affects a specific drug after administration through the mechanisms of absorption and distribution, as well as the chemical changes of the substance in the body (e.g. by metabolic enzymes such as cytochrome P450 or glucuronosyltransferase enzymes), and the effects and routes of excretion of the metabolites of the drug. Pharmacokinetic properties of drugs may be affected by elements such as the site of administration and the dose of administered drug. These may affect the absorption rate. Pharmacokinetics is often studied in conjunction with pharmacodynamics, the study of a drug's pharmacological effect on the body.A number of different models have been developed in order to simplify conceptualization of the many processes that take place in the interaction between an organism and a drug. One of these models, the multi-compartment model, gives the best approximation to reality; however, the complexity involved in using this type of model means that monocompartmental models and above all two compartmental models are the most-frequently used. The various compartments that the model is divided into are commonly referred to as the ADME scheme (also referred to as LADME if liberation is included as a separate step from absorption): Liberation - the process of release of a drug from the pharmaceutical formulation. See also IVIVC. Absorption - the process of a substance entering the blood circulation. Distribution - the dispersion or dissemination of substances throughout the fluids and tissues of the body. Metabolization (or biotransformation, or inactivation) – the recognition by the organism that a foreign substance is present and the irreversible transformation of parent compounds into daughter metabolites. Excretion - the removal of the substances from the body. In rare cases, some drugs irreversibly accumulate in body tissue.The two phases of metabolism and excretion can also be grouped together under the title elimination.The study of these distinct phases involves the use and manipulation of basic concepts in order to understand the process dynamics. For this reason in order to fully comprehend the kinetics of a drug it is necessary to have detailed knowledge of a number of factors such as: the properties of the substances that act as excipients, the characteristics of the appropriate biological membranes and the way that substances can cross them, or the characteristics of the enzyme reactions that inactivate the drug.All these concepts can be represented through mathematical formulas that have a corresponding graphical representation. The use of these models allows an understanding of the characteristics of a molecule, as well as how a particular drug will behave given information regarding some of its basic characteristics. Such as its acid dissociation constant (pKa), bioavailability and solubility, absorption capacity and distribution in the organism.The model outputs for a drug can be used in industry (for example, in calculating bioequivalence when designing generic drugs) or in the clinical application of pharmacokinetic concepts. Clinical pharmacokinetics provides many performance guidelines for effective and efficient use of drugs for human-health professionals and in veterinary medicine.