NPS MedicineWise

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024
Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

New Omdia Research Paper Highlights Need for Broadband Service Providers to Focus on Latency and Quality of Experience for Home Wi-Fi

Retrieved on: 
Thursday, October 19, 2023
Cloud, Acceleration, Cable, NFF, Reading, Congress, NPS, FTTH, Conference, Home automation, Internet, C22, NPS MedicineWise, Nature, Marketing, Network, XR, Quality, Key, AR, Service, Wireless Broadband Alliance, Dömös, Internet service provider, Mobile phone, Research, Wi-Fi, Quality of experience

The paper, written by Michael Philpott, Omdia Research Director, Service Provider–Consumer, highlights the global acceleration of ultra-high-speed Internet, the growing need for operators to focus on latency, and the importance of deploying in-home Smart Wi-Fi to enhance Quality of Experience (QoE) for subscribers.

Key Points: 
  • The paper, written by Michael Philpott, Omdia Research Director, Service Provider–Consumer, highlights the global acceleration of ultra-high-speed Internet, the growing need for operators to focus on latency, and the importance of deploying in-home Smart Wi-Fi to enhance Quality of Experience (QoE) for subscribers.
  • But speed alone will no longer be a competitive advantage for broadband operators.
  • This new report from Omdia addresses key considerations around latency and QoE, and we're pleased to help make it available to broadband service providers around the globe."
  • Data from this new report demonstrates the critical need for broadband service providers to deploy Smart Wi-Fi software that can monitor, predict, and solve performance issues.

Bain & Company: 25% of US clinicians want to leave healthcare and 33% want to switch employers

Retrieved on: 
Tuesday, October 11, 2022
Pressure, Physician, Bain & Company, Culture, City, AAMC, Attention, Platinum, Education, Organization, Patient, Research, Workforce, Mental health, RN, Workload, Technology, Decision-making, Human, Company, Economic development, MD, Industry, NSI, Ecosystem, Health, NPS, Social justice, NPS MedicineWise, Environment, Nursing, National health insurance, App, Solution, Medicine, Pharmaceutical industry, Health care

BOSTON, Oct. 11, 2022 /PRNewswire/ -- The challenging working environment of the last two years continues to have a significant impact on US clinicians including physicians, advanced practice providers (APPs) and nurses. Bain & Company's Frontline of Healthcare survey reveals that a quarter of US clinicians are considering switching careers and a third are considering switching employers. Additionally, the research shows that around half of clinicians surveyed report their mental health has declined since the start of the pandemic.

Key Points: 
  • Bain & Company's Frontline of Healthcare survey reveals that a quarter of US clinicians are considering switching careers and a third are considering switching employers.
  • Additionally, the research shows that around half of clinicians surveyed report their mental health has declined since the start of the pandemic.
  • Of the 25% of clinicians considering leaving careers in healthcare, 89% cite burnout as the primary reason.
  • Their dissatisfaction is also illustrated by drastically dropping Net Promoter Scores (NPS), a measure of their likelihood to recommend their employer.

Adamis Pharmaceuticals Provides Launch and Marketing Update for SYMJEPI

Retrieved on: 
Wednesday, August 28, 2019
Health, Articles, Medicine, Pharmaceuticals policy, Drug Safety, Alternative medicine, Botany, Herbal medicine, Over-the-counter drug, Medication, Vitamin, NPS MedicineWise

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Key Points: 
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of SYMJEPI.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • SYMJEPI may affect the way other medicines work, and other medicines may affect how SYMJEPI works.