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The Epidemiology of Drug Abuse

Details: According the National Survey of Drug Use and Health, in 2019, 57.2 million people aged ≥12 used illicit drugs in the past year. This represents an increase in percentage of people using illicit drugs, increasing from 17.8% in 2015 to 20.8% in 2019.

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The Anticholinergic Drug Scale as a Measure of Drug

Details: All level 1 drugs were considered to contribute a score of 1, regardless of dose. The dose-adjusted scores for all drugs received by a given subject were then summed to determine a total dose-adjusted score for that subject. Statistical Analysis. All statistical analyses were performed using SAS version 9.1 (SAS Institute Inc, Cary, NC).

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How Often Are Drugs Made Available Under the Food and Drug

Details: During the study period, for drugs not previously approved in any dosage form or for any indication, 24% of unique drugs and 20% of INDs received marketing approval by 1 year after initial submission; 43% and 33%, respectively, were approved by 5 years after initial submission. Expanded access provides just that: access.

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An Empirical Analysis of Japan's Drug Development Lag

Details: The “Drug lag” (i.e., the approval lag for new drugs) hinders patients’ access to innovative, new medicines. The drug lag had been heavily debated in Japan from the late 2000s to the early 2010s. It

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Drug‐induced Proarrhythmia and Torsade de Pointes: A

Details: While this regulatory paradigm has been successful in preventing drugs with unanticipated potential for inducing the rare but potentially fatal polymorphic ventricular arrhythmia torsade de pointes from entering the market, it has led to the termination of drug development programs for other potentially useful medicines because of isolated

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Examination of 209 Drugs for Inhibition of Cytochrome P450

Details: The 209 drugs were first tested at 30 μM for their ability to inhibit rhCYP2C8. Forty-eight compounds exhibited greater than 50% inhibition and were further evaluated for measurement of IC 50 . The six most potent inhibitors (IC 50 <1 μM) from this set were measured for IC 50 in pooled human liver microsomes, and the most potent inhibitor

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A Review on Drug‐Induced Nephrotoxicity

Details: A variety of marketed drugs belonging to various therapeutic classes are known to cause nephrotoxicity. Nephrotoxicity can manifest itself in several forms depending on the specific site involved as well as the underlying pathophysiological mechanisms.

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A Classification of Drug Action Based on Therapeutic

Details: A systematic classification system has been developed for the categorization of therapeutic effects of individual drugs based on their relationships to the underlying disease processes being treated or prevented, rather than on the pharmacologic or biochemical effects …

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A Systematic Review and Empirical Analysis of the Relation

Details: However, it has been suggested that this relation does not extend to drugs whose metabolites are active or slowly eliminated, drugs with saturable kinetics, and drugs with hit-and-run effects. The purpose of this study is to test this hypothesis and to quantify the relationship by way of a systematic review coupled to an empirical analysis.

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Efficacy and safety of adjunctive serotonin‐dopamine

Details: These drugs have been proposed to have a beneficial effect on cognition, sleep-related problems, and other affective symptoms in patients of depression. Previous studies have shown inconsistent evidence and have not reported a pooled effect of the two drugs of this class viz., aripiprazole and brexpiprazole.

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› Url: https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.2022 Go Now

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Survey of Japanese Orphan Drug

Details: The proportion of approved drugs was 77% (307 of 398). About 38% (152 of 398) of the drugs were approved within 24 months of orphan designation. The proportion of drugs submitted for approval within 3 months or 6 months from orphan designation acquisition was 3.3% (13 of 398) and 9% (36 of 398), respectively.

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A Review and Assessment of Potential Sources of Ethnic

Details: A few examples of suspected ethnic differences in pharmacokinetics or pharmacodynamics were identified. The available literature, however, was found to be heterologous, including a variety of study designs and research methodologies, and most of the publications were on drugs that were approved a long time ago.

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Drug Delivery Systems. 6. Transdermal Drug Delivery

Details: Basically, four systems are available that allow for effective absorption of drugs across the skin. The microsealed system is a partition-controlled delivery system that contains a drug reservoir with a saturated suspension of drug in a water-miscible solvent homogeneously dispersed in a silicone elastomer matrix.

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A Classification of Drug Action Based on Therapeutic

Details: A systematic classification system has been developed for the categorization of therapeutic effects of individual drugs based on their relationships to the underlying disease processes being treated or prevented, rather than on the pharmacologic or biochemical effects …

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Accelerating Drug Development in Pediatric Oncology With

Details: A recent review of molecularly targeted oncology drugs suggested that studies in pediatrics based on molecular mechanism of action, rather than indication, may accelerate drug development in pediatrics. 4 For prescribers and patients, information on the use of drugs in children may not be available until several years after the initial approval

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Ontogeny of Phase I Metabolism of Drugs

Details: CYP3A5: CYP3A activity is relevant in the metabolic clearance of a variety of drugs, such as clopidogrel or tacrolimus. In patients beyond the first year after transplantation, there is a cumulative effect of CYP3A5*1 polymorphism and weight on tacrolimus clearance.

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Use of Probe Drugs as Predictors of Drug Metabolism in

Details: The pharmacokinetics of many drugs often vary considerably among individuals, largely because of variations in the expression of different cytochrome P-450 (CYP) enzymes in the liver and other tissues. Relatively selective substrate probes in vivo have been discovered for several major CYP isoforms involved in oxidative drug metabolism

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Differences in Drug Pharmacokinetics Between East Asians

Details: Differences in metabolism between East Asians and Caucasians are common, especially in the activity of several phase I enzymes such as CYP2D6 and the CYP2C subfamily. Before drug therapy, identification of either the genotype and/or the phenotype for these enzymes may be of therapeutic value, particularly for drugs with a narrow therapeutic index.

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Critical Considerations in Anticancer Drug Development and

Details: Adding to the complexity of applying TDM and adaptive adjustment of cytotoxic doses is the typical use of combinations of at least 2 drugs, but often 3, 4, or even more drugs. Thus, such models are often developed in smaller academic studies after the drug has been marketed. Conclusions. Time has proven Galen wrong.

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Role of Hepatic Drug Transporters in Drug Development

Details: Membrane transporters play a key role in the uptake clearance of many drugs from hepatic sinusoidal blood (PS inf) and in the excretion of parent compounds and/or metabolites from hepatocytes into bile (CL int,bile) or the systemic circulation (PS eff). 3 Alteration in activities of hepatic transporters due to drug-drug interaction (DDI), genetic polymorphisms, and …

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Drug Transporters Expressed in the Human Placenta and

Details: Drug transporters are of paramount importance for drug exposure, and many research efforts have consequently been directed to elucidate the ontogeny of these transporters in fetuses, neonates, infants, and children. 1-3 In addition to the expression of these transporters in tissues such as the intestinal tract, drug exposure in preterm and term neonates may also …

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The New Drug Approvals of 1987, 1988, and 1989: Trends in

Details: The mean NDA phase for 1A drugs was 2.4 years; 1B drugs, 2.9 years; 1C drugs, 3.1 years; 1AA drugs, 1.4 years; and orphan drugs, 2.5 years. Forty-four of the 55 NCEs (80%) were available in foreign markets before US approval was given, with a …

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Pharmacokinetics of a Fixed‐Dose Combination of Amlodipine

Details: The PK parameters of these drugs were calculated using a noncompartmental method. Sixty subjects completed the study. The geometric mean ratios and 90% confidence intervals of maximum plasma concentration and area under the concentration–time curve to the last measurable point for amlodipine, losartan, and chlorthalidone were within the

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Importance of Hepatic Transporters in Clinical Disposition

Details: Biliary excretion of parent drugs is a less prevalent clearance pathway than metabolism or urinary excretion, but BCRP and MRP2 are critically important to biliary/fecal elimination of drug metabolites. Inhibition of biliary excretion is typically not apparent at the level of systemic pharmacokinetics but can markedly increase liver exposure

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Decision Science for Generic Drug Development and Review

Details: Generic drugs improve patient access to affordable medications, and the public wants generic versions of pharmaceutical products available as soon as legally possible. However, the majority of reference products that do not have available generics (even though patents and exclusivity no longer block generic competition) are concentrated in the

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Clinical Pharmacology of NSAIDs

Details: These drugs are subject to drug interactions of several mechanisms, including protein-binding-displacement interactions, induction or inhibition of hepatic drug metabolism, and competition for active renal tubular secretion with other organic acids. NSAIDs are also subject to special pharmacokinetic considerations about which a great deal has

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Basic and Clinical Pharmacology of Amiodarone

Details: Unlike most other cardiovascular drugs, it has been recognized for more than 20 years that optimal antiarrhythmic effects may take several days to weeks after onset of oral therapy. Amiodarone is highly lipid soluble and exhibits at least three separate compartments of drug distribution, with a long elimination half-life of 14–120 days after

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Management of Hypertension With a Fixed‐Dose (Single‐Pill

Details: Although many effective drugs are available, combinations of 2 or more medications are often required to meet clinical targets. Combination therapy has several advantages over monotherapy: lower doses of each drug can be used to achieve therapeutic goals; lower doses may lead to fewer adverse events, facilitating patient adherence; and using

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The Role of Transporters in the Toxicity of

Details: Drugs such as β-lactam antibiotics, which possess a quaternary nitrogen as carnitine does, are able to interfere with carnitine transport by hOCTN2 and to cause carnitine deficiency. 42 Multidrug and toxic compound extrusion (MATE) proteins mediate the H + -coupled electroneutral exchange of endogenous and exogenous OCs as their final

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Pediatric Drug‐Drug Interaction Evaluation: Drug, Patient

Details: Drugs that are metabolized by CYP3A4 may also be substrates for CYP3A7 in neonates and young infants. The switch from CYP3A7 to CYP3A4 has been reported to occur in the first 3 months of life, which can impact CL predictions. 23.

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The Importance of Stereochemistry in Drug Action and

Details: The pharmacokinetic profiles of enantiomers can be variable, especially for drugs with a first-pass effect and enantioselective pharmacokinetic monitoring should be carried out. Ultimately, whether to exploit a racemate or a single enantiomer in therapy is a multi-faceted decision to which drug disposition data have important contributions to make.

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Bioequivalence study designs for generic solid oral

Details: The demonstration of bioequivalence (BE) between the test and reference products is an integral part of generic drug approval process. A sound BE study design is pivotal to the successful demonstration of BE of generic drugs to …

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Pharmacokinetics, Safety, and Tolerability of Fevipiprant

Details: The key exclusion criteria included a history of alcohol or drug abuse; acute or chronic bronchospastic disease; use of any prescription drugs within 4 weeks or over-the-counter medications within 2 weeks before dosing; clinically significant electrocardiogram (ECG) abnormalities; and photosensitive reactions to medications, topical creams, or

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Efficacy of Antidepressants as Analgesics: A Review

Details: Antidepressant drugs have analgesic effects in chronic rheumatic painful states in which nonsteroi dal anti-inflammatory drugs (NSAIDs) are not very efficient, such as fibromyalgia.39 Peripheral neuro pathic pain is the pain condition for which the great-est amount of evidence for the therapeutic use of antidepressants exists.

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Pharmacokinetic Properties of Ibuprofen (IBU) From the

Details: After intake of a standard breakfast, study medication was administered in a standing position according to the randomization schedule. The 2 treatment periods (each of which included a profile period of 24 hours) were separated by a washout period of at least 6 calendar days between consecutive administrations of study drugs.

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Bioequivalence and Pharmacokinetic Evaluation of 2

Details: Pyrazinamide (PZA), also known as isonicotinamide, is a nicotinamide structural analog with unique sterilization activity. Unlike other antituberculosis (anti-TB) drugs, PZA can kill tuberculosis bacteria and retention bacteria in the semidormant period under acidic conditions.

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Evaluation and Quantitative Prediction of Renal

Details: Excretion of unchanged drug in urine is a major clearance pathway for the market drugs. A recent analysis suggested that approximately 30% of approved drugs show renal clearance as the predominant clearance mechanism. 1 According to the extended clearance classification system (ECCS), a validated framework for early identification of the rate …

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Risk of Hypoglycemia After Concomitant Use of Antidiabetic

Details: The primary outcome was the report of hypoglycemia. The Norén and Gosho methods, which quantitatively measure the discrepancy between the observed and expected number of adverse events under the combination of 2 drugs, were used as the criteria for detecting drug-drug interactions.

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Enzyme‐ and transporter‐mediated beverage–drug

Details: For CYP3A-mediated beverage–drug interaction, the in vivo CYP3A inhibitory effect is limited to grapefruit juice (GFJ), which increases the bioavailability of several orally administered drugs that undergo extensive first-pass metabolism via enteric CYP3A.

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Association Between the Use of Sodium‐Glucose

Details: In the US Food and Drug Administration's Adverse Event Reporting System analysis, disproportionality for AKI was observed between DPP-4 inhibitor users and SGLT-2 inhibitor users administered nonsteroidal anti-inflammatory drugs (reporting odds ratio, 0.65; 95%CI, 0.48-0.88; P < .01) and thiazide diuretics (reporting odds ratio, 0.78; 95%CI, 0

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EvaluationandQuantitativePredictionof RenalTransporter

Details: the large concentration gradient of drugs developed with water reabsorbed along the nephron lumen. At the same time, drugs and metabolites could also be reabsorbed via transporter-mediated process in the renalproximaltubules.Therefore,renalDDIsmayalso arise through inhibition of transporters involved in activereabsorption.However

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Human Liver Aldehyde Oxidase: Inhibition by 239 Drugs

Details: The authors tested 239 frequently used drugs and other compounds for their potential to inhibit the drug-metabolizing enzyme, aldehyde oxidase, in human liver cytosol. A sensitive, moderate throughput HPLC-MS assay was developed for 1-phthalazinone, the aldehyde oxidase–catalyzed product of phthalazine oxidation.

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Hypothermia Associated With Antipsychotic Drug Use: A

Details: Antipsychotic drugs with strong 5-HT2 antagonism seem to be more frequently associated with hypothermia. These cases demonstrate the clinical relevance of hypothermia as an adverse reaction to antipsychotic treatment and the importance of careful monitoring of body temperature. Citing Literature. Volume 52, Issue 7.

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Evaluation of the CYP3A and CYP2B6 Drug‐Drug Interaction

Details: Per US Food and Drug Administration guidance, the choice of drugs evaluated in the phase 1 studies included itraconazole and fluconazole (strong and moderate CYP3A inhibitors, respectively), rifampin (strong CYP3A inducer), midazolam (CYP3A substrate), and bupropion (CYP2B6 substrate). Methods

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Dose‐Finding Studies Among Orphan Drugs Approved in the EU

Details: Two orphan drugs (carglumic acid [Carbaglu] and miglustat [Zavesca]) were authorized for 2 different disease indications, adding up to a total of 28 orphan drugs. Ten orphan drugs were withdrawn from the community register of orphan drugs at the end of the 10-year period of market exclusivity.

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A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel

Details: LYT-100 is designed to have a differentiated pharmacokinetic (PK) profile from pirfenidone and could offer a differentiated safety profile compared to current standard-of-care drugs while retaining the biochemical potency and specificity of pirfenidone.

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