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Monetary asmmetries without (and with) price stickiness

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Friday, April 19, 2024

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Key Points:

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on:

Thursday, April 18, 2024

17

Key Points:

17
Guideline on the pharmaceutical quality of inhalation and
nasal medicinal products

18

Table of contents

19

Executive summary ..................................................................................... 3

20

1.
Lifecycle management ........................................................................................ 28
49

Definitions ................................................................................................. 29

16

50
51

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 2/30

52

Executive summary

53

This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

54

products (EMEA/CHMP/QWP/49313/2005 Corr).
Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for
66

safety testing (e.g., for excipients and leachables) is also considered.
69
Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

70

analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

71

impactor analysis) is not included in this guideline.
Scope
74

The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

75

new marketing authorisation applications, including abridged applications.
Liquid inhalation anaesthetics and nasal ointments, creams and gels are
88

excluded, however the general principles described in this guideline should be considered.
118
Different polymorphic forms including any amorphous content could affect the quality or performance

119

of the finished medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 4/30

132

The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

133

components required for reasons of stability should be described.
Pharmaceutical
development study
(a) Physical
characterisation
(b) Minimum fill
justification
(c) Extractable
volume

Pressurised

Dry powder

Preparations for

Non-

metered-

inhalers (DPI)

nebulisation

pressurised

dose

metered-

Device-

Pre-

Single-

Multi-

(pMDI)

metered

metered

dose

dose

inhalers

Yesa

Yes

Yes

Yesa

Yesa

Yesa

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

Yes

No

No

inhalers

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

dose

Page 5/30

Table 4.2.1.
The last doses delivered by
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 7/30

179

the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

180

for delivered dose and fine particle dose.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 9/30

263
264

4.2.2.8.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 11/30

345

Instructions regarding cold temperature use should be provided in the product information.
Finished medicinal
product
Pressurised

Dry powder inhalers

Preparations for

metered-

(DPI)

nebulisation

dose

Nonpressurised
metered-dose

Device-

Pre-

Single-

Multi-

(pMDI)

metered

metered

dose

dose

inhalers

(a) Description

Yes

Yes

Yes

Yes

Yes

Yes

(b) Assay

Yes

Yes

Yes

Yes

Yes

Yes

(c) Moisture content

Yes

Yes

Yes

No

No

No

Yes

Yes

Yes

No

No

Yes

Yes

Yes

Yes

No

No

Yes

specification test

(d) Mean delivered
dose
(e) Uniformity of
delivered dose

inhalers

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 15/30

Table 4.2.2.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 16/30

510

4.2.5.4.
The proposed specification limits should take into account the shelf-life performance of the
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 17/30

552

medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 18/30

586

All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

587

outlined in the Medical Device Regulation (EU) 2017/745.
Stability (CTD 3.2.P.8)
598

All inhalation medicinal products should be tested on stability against the stability indicating tests

599

included in the finished medicinal product specification.
Quality data requirements as
619

described in this guideline should be met, supplemented by appropriate comparative quality and

620

clinical data with respect to the chosen reference medicinal product.
621
For inhalation medicinal products comparative in vitro data between the abridged application medicinal

622

product and the reference medicinal product must be provided.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 20/30

670

Nature and contents of container: The type of the device and its components should be listed.
Nasal medicinal products
695

Inhalation and nasal medicinal products have many similarities and therefore, most of the

696

requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

697

products.
One difference between inhalation and nasal medicinal products is the desired
698

particle/droplet size of the finished medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 21/30

704

5.2.
Nasal liquids
Pharmaceutical
development
study
Pressurised

Nasal

metered-

powders,

dose nasal

device-

spray

metered

NonSingledose
drops

Multidose
drops

Single-

pressurised

dose

multidose

spray

metereddose spray

(a) Physical
characterisation
(b) Minimum fill
justification
(d) Extractables /
leachables

Yesa

Yes

Yesa

Yesa

Yesa

Yesa

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Yes

Yes

Yes

Yes

No

No

No

Yes

Yes

Yes

No

No

Yes

Yes

(f) Particle /
droplet size
distribution
(g) Uniformity of
delivered dose
through container
life
(j) Actuator /
mouthpiece
deposition

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 22/30

Table 5.2.1.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 23/30

728

5.2.2.2.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 24/30

769

5.2.5.
Quality data requirements as described in
799

this guideline should be met, supplemented by appropriate comparative quality and clinical data with

800

respect to the chosen reference medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 27/30

849

5.5.
866
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 28/30

867

Definitions
Activation:

The act of setting in motion the delivery device.
Delivery device:
The sum of component(s) of the container closure system responsible for
delivering the active substance to the respiratory tract (inhalation medicinal
product) or the nasal and/or pharyngeal region (nasal medicinal product).
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 29/30

Label claim:

The amount of active substance (usually on a per actuation basis) declared
on the label of the medicinal product.
Nasal medicinal
A finished medicinal product (including the delivery device, where

product:

applicable) whose intended site of deposition is the nasal and/or pharyngeal
region.
868
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 30/30

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on:

Thursday, April 18, 2024

17

Key Points:

17
Guideline on the pharmaceutical quality of inhalation and
nasal medicinal products

18

Table of contents

19

Executive summary ..................................................................................... 3

20

1.
Lifecycle management ........................................................................................ 28
49

Definitions ................................................................................................. 29

16

50
51

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 2/30

52

Executive summary

53

This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

54

products (EMEA/CHMP/QWP/49313/2005 Corr).
Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for
66

safety testing (e.g., for excipients and leachables) is also considered.
69
Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

70

analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

71

impactor analysis) is not included in this guideline.
Scope
74

The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

75

new marketing authorisation applications, including abridged applications.
Liquid inhalation anaesthetics and nasal ointments, creams and gels are
88

excluded, however the general principles described in this guideline should be considered.
118
Different polymorphic forms including any amorphous content could affect the quality or performance

119

of the finished medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 4/30

132

The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

133

components required for reasons of stability should be described.
Pharmaceutical
development study
(a) Physical
characterisation
(b) Minimum fill
justification
(c) Extractable
volume

Pressurised

Dry powder

Preparations for

Non-

metered-

inhalers (DPI)

nebulisation

pressurised

dose

metered-

Device-

Pre-

Single-

Multi-

(pMDI)

metered

metered

dose

dose

inhalers

Yesa

Yes

Yes

Yesa

Yesa

Yesa

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

Yes

No

No

inhalers

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

dose

Page 5/30

Table 4.2.1.
The last doses delivered by
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 7/30

179

the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

180

for delivered dose and fine particle dose.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 9/30

263
264

4.2.2.8.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 11/30

345

Instructions regarding cold temperature use should be provided in the product information.
Finished medicinal
product
Pressurised

Dry powder inhalers

Preparations for

metered-

(DPI)

nebulisation

dose

Nonpressurised
metered-dose

Device-

Pre-

Single-

Multi-

(pMDI)

metered

metered

dose

dose

inhalers

(a) Description

Yes

Yes

Yes

Yes

Yes

Yes

(b) Assay

Yes

Yes

Yes

Yes

Yes

Yes

(c) Moisture content

Yes

Yes

Yes

No

No

No

Yes

Yes

Yes

No

No

Yes

Yes

Yes

Yes

No

No

Yes

specification test

(d) Mean delivered
dose
(e) Uniformity of
delivered dose

inhalers

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 15/30

Table 4.2.2.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 16/30

510

4.2.5.4.
The proposed specification limits should take into account the shelf-life performance of the
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 17/30

552

medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 18/30

586

All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

587

outlined in the Medical Device Regulation (EU) 2017/745.
Stability (CTD 3.2.P.8)
598

All inhalation medicinal products should be tested on stability against the stability indicating tests

599

included in the finished medicinal product specification.
Quality data requirements as
619

described in this guideline should be met, supplemented by appropriate comparative quality and

620

clinical data with respect to the chosen reference medicinal product.
621
For inhalation medicinal products comparative in vitro data between the abridged application medicinal

622

product and the reference medicinal product must be provided.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 20/30

670

Nature and contents of container: The type of the device and its components should be listed.
Nasal medicinal products
695

Inhalation and nasal medicinal products have many similarities and therefore, most of the

696

requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

697

products.
One difference between inhalation and nasal medicinal products is the desired
698

particle/droplet size of the finished medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 21/30

704

5.2.
Nasal liquids
Pharmaceutical
development
study
Pressurised

Nasal

metered-

powders,

dose nasal

device-

spray

metered

NonSingledose
drops

Multidose
drops

Single-

pressurised

dose

multidose

spray

metereddose spray

(a) Physical
characterisation
(b) Minimum fill
justification
(d) Extractables /
leachables

Yesa

Yes

Yesa

Yesa

Yesa

Yesa

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Yes

Yes

Yes

Yes

No

No

No

Yes

Yes

Yes

No

No

Yes

Yes

(f) Particle /
droplet size
distribution
(g) Uniformity of
delivered dose
through container
life
(j) Actuator /
mouthpiece
deposition

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 22/30

Table 5.2.1.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 23/30

728

5.2.2.2.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 24/30

769

5.2.5.
Quality data requirements as described in
799

this guideline should be met, supplemented by appropriate comparative quality and clinical data with

800

respect to the chosen reference medicinal product.
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 27/30

849

5.5.
866
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024

Page 28/30

867

Definitions
Activation:

The act of setting in motion the delivery device.
Delivery device:
The sum of component(s) of the container closure system responsible for
delivering the active substance to the respiratory tract (inhalation medicinal
product) or the nasal and/or pharyngeal region (nasal medicinal product).
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 29/30

Label claim:

The amount of active substance (usually on a per actuation basis) declared
on the label of the medicinal product.
Nasal medicinal
A finished medicinal product (including the delivery device, where

product:

applicable) whose intended site of deposition is the nasal and/or pharyngeal
region.
868
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
EMA/CHMP/20607/2024
Page 30/30

Healis Therapeutics announces collaboration with Massachusetts General Hospital (MGH) and affiliates of Harvard Medical School to advance clinical-stage neuroscience research

Retrieved on:

Tuesday, March 26, 2024

Healis Therapeutics is pleased to announce that it has entered a clinical collaboration with Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health system, and affiliates of Harvard Medical School (HMS).

Key Points:

Healis Therapeutics is pleased to announce that it has entered a clinical collaboration with Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham health system, and affiliates of Harvard Medical School (HMS).
“We continue to observe very significant need in the neuropsychiatric patient population,” said Dr. Eric Finzi, Co-Founder of Healis Therapeutics.
“MDD remains a public health challenge around the world,” said Erik Van Widenfelt, Head of Clinical Trials at Healis Therapeutics.
General Hospital (MGH) and Harvard Medical School,” said Sebastian De Beurs, Co-Founder of Healis Therapeutics.

EverythingALS Launches the Vision 2030 AI Hub: Charting the Path to an ALS Cure and Advancing Neurodegenerative Disease Research

Retrieved on:

Tuesday, March 12, 2024

The Vision 2030 AI Hub will have a laser focus on "repair and regeneration," aiming to distinguish the organization in the ALS research landscape.

Key Points:

The Vision 2030 AI Hub will have a laser focus on "repair and regeneration," aiming to distinguish the organization in the ALS research landscape.
The Vision 2030 AI Hub epitomizes this momentous convergence—where the cumulative advances in ALS research and technology coalesce, heralding a new epoch of hope and discovery.
The Vision 2030 AI Hub motivates giving and fundraising, showcasing an innovative operating model that emphasizes urgency in tackling ALS and other disorders.
For more information about EverythingALS, Vision 2030, and the AI Hub visit http://www.v2030.org or email us at [email protected] .

Viz.ai® Announces Three New Studies Supporting Viz HCM™ Module for the Detection and Management of Suspected Hypertrophic Cardiomyopathy

Retrieved on:

Wednesday, April 3, 2024

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data supporting advancements in cardiology care.

Key Points:

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data supporting advancements in cardiology care.
The Viz HCM module is the first and only AI algorithm cleared by the FDA for HCM.
The study found that Viz HCM performance in suspected HCM detection was consistent across various racial backgrounds with a sensitivity of 68.4% and specificity of 99.1%.
This validates the effectiveness of relevance score sorting for prioritizing higher probability HCM-positive patients identified by deep-learning algorithms analyzing ECG data.

Insights on Leading Employers in Top Business Sectors and Insurers that Serve Them by Mark Farrah Associates

Retrieved on:

Monday, March 25, 2024

Mark Farrah Associates (MFA), www.markfarrah.com , presents a high-level analysis of the leading employers in top business sectors, as well as the key health benefit insurers that serve them, utilizing information from MFA’s 5500 Employer Health Plus product.

Key Points:

Mark Farrah Associates (MFA), www.markfarrah.com , presents a high-level analysis of the leading employers in top business sectors, as well as the key health benefit insurers that serve them, utilizing information from MFA’s 5500 Employer Health Plus product.
Large private-sector employers providing health and welfare benefit plans subject to ERISA are required to file the annual Form 5500 with the Internal Revenue Service.
Observations obtained from 5500 Employer Health Plus are based on 86,200 employers that indicated they had active health benefit contracts as of their most recent filings.
Private-sector employers reported 89.7 million potential plan participants across the spectrum of all health benefit contracts.

SWAYE Unveils ‘Web3's Most-Accessible Game: The OG Battlefront’ on Sui

Retrieved on:

Friday, March 22, 2024

Technology, Professional Services, Electronic Games, Online, Blockchain, Web3, General Entertainment, Entertainment, Software, Cryptocurrency, Internet, Community, Internet celebrity, Apple, WAYE, Community Participation, Mass, OG, Community engagement

This groundbreaking initiative is made possible with The Sui Foundation , leveraging SWAYE's proprietary technology, SWAYE Login , and Sui's cutting-edge blockchain infrastructure.

Key Points:

This groundbreaking initiative is made possible with The Sui Foundation , leveraging SWAYE's proprietary technology, SWAYE Login , and Sui's cutting-edge blockchain infrastructure.
"The OG Battlefront" is more than just a game; it taps into the nostalgia of the OG arcade games and web3 culture.
Users can create a blockchain account, receive a Sui wallet, OG Collectible, and start playing in seconds - all within Telegram.
These tokens are used to upgrade their dynamic OG Collectible, which serves as playable characters in "The OG Battlefront", enhancing both rarity and in-game advantages.

GE HealthCare and Mass General Brigham Evolve Their AI Collaboration with Medical Imaging Foundation Models

Retrieved on:

Tuesday, March 12, 2024

Based on its long-term artificial intelligence (AI) partnership, GE HealthCare and Mass General Brigham plan to integrate medical imaging foundation models into their AI research work, with a strong focus on responsible AI practices.

Key Points:

Based on its long-term artificial intelligence (AI) partnership, GE HealthCare and Mass General Brigham plan to integrate medical imaging foundation models into their AI research work, with a strong focus on responsible AI practices.
“The relationship between Mass General Brigham’s commercial AI business (Mass General Brigham AI) and GE HealthCare has helped accelerate the introduction of AI into a range of product offerings and digital health solutions.
Foundation models have emerged as a reliable and adaptable foundation for developing AI applications tailored to the healthcare sector.
“GE HealthCare and Mass General Brigham have a long-standing AI collaboration that has produced AI-powered tools which help increase operational effectiveness and productivity.

Implantable Brain-Computer Interface Collaborative Community (iBCI-CC) to Drive Innovation in Neurotechnology

Retrieved on:

Monday, March 11, 2024

Mass General Brigham is establishing the Implantable Brain-Computer Interface Collaborative Community (iBCI-CC).

Key Points:

Mass General Brigham is establishing the Implantable Brain-Computer Interface Collaborative Community (iBCI-CC).
This is the first Collaborative Community in the clinical neurosciences that has participation from the U.S. Food and Drug Administration (FDA).
BCIs are devices that interface with the nervous system and use software to interpret neural activity.
This collaborative effort aims to propel the field of iBCIs forward by employing harmonized approaches that drive continuous innovation and ensure equitable access to these transformative technologies.