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FORMULATION DEVELOPMENT AND EVALUATION OF NOVEL ORAL SOLUBLE FILMS OF
FORMULATION DEVELOPMENT AND EVALUATION OF NOVEL ORAL SOLUBLE FILMS OF

... medications. According to NICE guidelines (2002) oral atypical antipsychotics are recommended as first-line treatment for patients with newly diagnosed schizophrenia[2]. Ziprasidone HCl (ZH) is a new atypical antipsychotic, proved to be effective in the treatment of schizophrenia and do not cause ag ...
Media Tip Sheet: MDMA / Molly / Ecstasy
Media Tip Sheet: MDMA / Molly / Ecstasy

... dangerously high increase in body if overdose played a role in these temperature, or heatstroke – is the most medical emergencies.” common health problem related to MDMA.9 Given the highly-adulterated molly market, it’s also more likely to see an unidentified substance cause problems, rather than MD ...
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... lack of meta-analyses and randomised controlled trials in this area. Most of the available evidence is based on only individual case reports and animal studies. ...
IN VITRO ARE YOU READY? DPT Thought Leadership Issue 16
IN VITRO ARE YOU READY? DPT Thought Leadership Issue 16

... In vitro release testing serves multiple functions in a drug’s life cycle. Recently, the US Pharmacopeia adopted General Chapter 1724 to define and standardize in vitro release testing standards for semi-solid formulations. As a result, regulatory agencies may now request companies to perform these ...
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... environmental factors, analytical test method limitations and specimen manipulation. Clearly, ‘true’ and ‘false’ UDT results are a limited subset of a larger universe of potentially misleading, inappropriate and unexpected UDT results. This larger universe, while not solely comprised of technically ...
OpioidAnalgesics_3
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... • Since then, it has been best known for its use in treating narcotic addiction, although such a use never became widespread and common until the early 1990's when public policy sought to find ways to reduce the spread of HIV and AIDS. ...
Therapeutic Drug Monitoring in Psychiatry
Therapeutic Drug Monitoring in Psychiatry

... risk groups that are exposed in normal everyday clinical practice but that are  underrepresented in the phases of drug development. The PK‐data were to be  assessed  by  samples  sent  to  the  Therapeutic  Drug  Monitoring  (TDM)  laboratory service. In a subset of individuals, the genotypes of the ...
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Assignments of PGDPSM – July 2015 Batch

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Symax DuoTab - Capellon Pharmaceuticals
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... maraviroc dosing schedules being utilized in clinical practice, reported similar maraviroc Ctrough exposure of 43 ng/mL (IQR 35 –55) to that seen in our study in the group receiving the same antiretroviral regimen.21 Within this cohort, when higher doses of maraviroc were utilized in clinical practi ...
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from membrane-embedded targets to amyloid fibrils

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Racial and Ethnic Differences in Response to Medicines
Racial and Ethnic Differences in Response to Medicines

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Codeine Intoxication in the Neonate
Codeine Intoxication in the Neonate

... The primary metabolic pathway of glucuronidation is low at birth, and the adult level is not reached until 3 years of age.13 Newborns have been noted to have a reduced ability to conjugate drugs with glucuronic acid and glycine but an increased capacity to conjugate them with sulfate.15 Therefore, c ...
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...  To describe the characteristics of foreign clinical data that will facilitate their extrapolation to different populations and support their acceptance as a basis for registration of a medicine in a new region  To describe regulatory strategies that minimize duplication of clinical data and facil ...
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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.
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