Taste

• The U.S. government moved closer to banning the video social media app TikTok after the House of Representatives attached the measure to an emergency spending bill on Apr.
• The move could improve the bill’s chances in the Senate, and President Joe Biden has indicated that he will sign the bill if it reaches his desk.
• The bill would force ByteDance, the Chinese company that owns TikTok, to either sell its American holdings to a U.S. company or face a ban in the country.
• For one, ByteDance can be required to assist the Chinese Communist Party in gathering intelligence, according to the Chinese National Intelligence Law.
• The fact that China, a country that Americans criticize for its authoritarian practices, bans social media platforms is hardly a reason for the U.S. to do the same.
• Here’s why I think the recent move against TikTok misses the larger point: Americans’ sources of information have declined in quality and the problem goes beyond any one social media platform.

The deeper problem

• But the proposed solution of switching to American ownership of the app ignores an even more fundamental threat.
• The deeper problem is not that the Chinese government can easily manipulate content on the app.
• It is, rather, that people think it is OK to get their news from social media in the first place.
• In other words, the real national security vulnerability is that people have acquiesced to informing themselves through social media.

Media and technology literacy

• Research suggests that it will only be alleviated by inculcating media and technology literacy habits from an early age.
• My colleagues and I have just launched a pilot program to boost digital media literacy with the Boston Mayor’s Youth Council.
• Some of these measures to boost media and technology literacy might not be popular among tech users and tech companies.

The Applied Ethics Center at UMass Boston receives funding from the Institute for Ethics and Emerging Technologies. Nir Eisikovits serves as the data ethics advisor to Hour25AI, a startup dedicated to reducing digital distractions.

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  Guideline on the requirements for demonstrating
  therapeutic equivalence between orally inhaled products
  (OIP) for asthma and chronic obstructive pulmonary
  disease (COPD)

  22

  Table of contents

  23

  Executive summary ..................................................................................... 4

  24

  1.

• Primary PK parameters to be analysed and acceptance criteria .............................. 14

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  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  51

  6.4.

• Definitions ........................................................................................... 18

  56

  List of Abbreviations.................................................................................. 20

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  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

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  Executive summary

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  This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

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  for clinical documentation for orally inhaled products (OIP) including the requirements for

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  demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

  62

  asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

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  asthma in children and adolescents?.

• It addresses the requirements for demonstration of therapeutic

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  equivalence (TE) between orally inhaled products containing the same active moiety(ies).

• It is generally not recommended to aim at demonstrating TE using pharmacodynamic

  70

  or clinical endpoints as these are deemed insensitive.

• This

  83

  guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

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  same active moiety(ies) and used in the management and treatment of patients with asthma and/or

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  COPD.

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  The guideline was first published as points to consider in 2004 and revised for the first time and

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  became guideline in 2009.

• Since then, a number of Q&A documents have been published by Quality

  88

  Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).

• Scope

  93

  This document provides guidance on the requirements for demonstrating TE between OIPs, including

  94

  both, single active substance products and combination products.

• Also, in the case that there is a need

  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  98

  to confirm similarity to a product for which literature data is available (e.g., well-established use

  99

  applications), the same principles apply.

• Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  132

  4.

• Products for nebulisation

  177

  This guideline applies also for products for nebulisation although it is acknowledged that the

  178

  performance of these is highly dependent on the nebuliser used.

• In vitro criteria for demonstrating TE

  206

  The test and reference products should be compared in order to conclude on TE.

• Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  211
  212

  2.

• Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

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  6.2.

• Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  392

  6.3.

• If the
  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  432

  different strengths of the test and the reference product are not shown to be proportional in vitro, in

  433

  vivo equivalence should be demonstrated with a bracketing approach.

• Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  471

  6.4.

• Griffin, 1964

  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  553

  which both reference product-na?ve and experienced users should be included.

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  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  569

  10.

• Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  Product strength

  Product strength may be either the delivered
  dose or the metered dose.

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  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

  571

  List of Abbreviations
  APSD

  Aerodynamic Particle Size Distribution

  AUC

  Area Under the Curve

  CHMP

  Committee for Medicinal Products for Human
  Use

  CI

  Confidence Interval

  Cmax

  Peak concentration

  COPD

  Chronic Obstructive Pulmonary Disease

  DPI

  Dry Powder Inhaler

  FPD

  Fine Particle Dose

  GI

  Gastrointestinal

  ICH

  International Conference on Harmonisation

  IVIVC

  In vitro in vivo correlation

  MDI

  Metered Dose Inhaler

  OIP

  Orally Inhaled Product

  PD

  Pharmacodynamic

  PK

  Pharmacokinetic

  pMDI

  Pressurised Metered Dose Inhaler

  QWP

  Quality Working Party

  SmPC

  Summary of Product Characteristics

  TE

  Therapeutic equivalence

  tmax

  Time to peak concentration

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  Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
  chronic obstructive pulmonary disease (COPD)
  EMA/CHMP/101453/2024

• It is alleged that Roman winemakers had to mask their products’ flaws by adding spices, herbs and other ingredients to the freshly pressed grape juice, which is known as must.
• Many of the longstanding misconceptions surrounding Roman wine come from a lack of insight into one of the most characteristic features of Roman winemaking: fermentation in clay jars or dolia.
• In our research, we compared Roman dolia with traditional Georgian production vessels, called qvevri, which are still in use today.

Porous eggs buried in the ground

• Unlike the metal or concrete containers used in modern winemaking, clay jars are porous, meaning the wine is exposed to air during fermentation.
• The Romans used pitch from pine resin, while nowadays, in Georgia, neutral beeswax is applied.
• By burying the vessels in the ground, winemakers can control temperature and provide a stable environment for wine to ferment and mature during its many months inside the jars.

Macerated wines

• In clay jar winemaking, however, white wines regularly undergo long macerations with the grape solids (skins, seeds, and so on).
• This wine – increasingly popular today – is similar to descriptions of some of the most prized wines in antiquity.

Protective yeast: the miracle of flor

• Many of these are what we call “flor” yeasts, a thick white foam layer that protects the wine from contact with the air.
• Flor produces several chemicals, including sotolon, which gives wine a spicy taste.

Roman wines revisited

• By varying the size, shape and the position of dolia, Roman winemakers were able to have great control over the end product, as Georgian winemakers do today.
• It not only debunks the alleged amateurish nature of Roman winemaking, but it also uncovers common traits in millennia-old winemaking techniques.

Dimitri Van Limbergen no recibe salario, ni ejerce labores de consultoría, ni posee acciones, ni recibe financiación de ninguna compañía u organización que pueda obtener beneficio de este artículo, y ha declarado carecer de vínculos relevantes más allá del cargo académico citado.

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