Light | Jotup

IceCube researchers detect a rare type of energetic neutrino sent from powerful astronomical objects

Retrieved on:

Thursday, April 25, 2024

Acceleration, Light, Energy, IceCube Neutrino Observatory, Machine learning, Galaxy, Travel, Ice, Eye, Mineral oil

In fact, only one of them is likely to lightly tap an atom in your body in your entire lifetime.

Key Points:

In fact, only one of them is likely to lightly tap an atom in your body in your entire lifetime.
While much rarer, these energetic neutrinos are more likely to crash into something and create a signal that physicists like me can detect.
IceCube, one such experiment, documented an especially rare type of particularly energetic astrophysical neutrino in a study published in April 2024.

IceCube observatory

The IceCube Neutrino Observatory is the 800-pound gorilla of large neutrino experiments.
But the tau neutrino, one type of particularly energetic neutrino, has eluded IceCube – until now.

Neutrino flavors

When a neutrino bangs into another particle, it usually produces a charged particle that corresponds with its flavor.
A muon neutrino produces a muon, an electron neutrino produces an electron, and a tau neutrino produces a tau.
The third flavor of neutrino, the tau neutrino, is the chameleon of the trio.
One tau neutrino can appear as a track of light, while the next can appear as a ball.

Energetic tau neutrinos

This data confirms IceCube’s earlier discovery of astrophysical neutrinos, and they confirm a hint that IceCube previously picked up of astrophysical tau neutrinos.
In particular, the detection of astrophysical tau neutrinos confirms that energetic neutrinos from distant sources change flavor, or oscillate.

As IceCube and other neutrino experiments gather more data, and scientists get better at distinguishing the three neutrino flavors, researchers will eventually be able to guess how neutrinos that come from black holes are produced.
There will always be fewer energetic tau neutrinos and their muon and electron cousins compared with the more common neutrinos that come from the Big Bang.

Doug Cowen receives funding from the National Science Foundation.

Our laser technique can tell apart elephant and mammoth ivory – here’s how it may disrupt the ivory trade

Retrieved on:

Thursday, April 25, 2024

In recent years, the global trade in elephant ivory has faced significant restrictions in an effort to protect dwindling elephant populations.

Key Points:

In recent years, the global trade in elephant ivory has faced significant restrictions in an effort to protect dwindling elephant populations.
The sale of mammoth ivory, sourced primarily from long-extinct species, however, remains unregulated.
But it’s a significant challenge for customs and law enforcement agencies to distinguish between ivory from extinct mammoths and living elephants.
Now our new study, published in PLOS ONE, presents a major breakthrough – using a well known laser technique to tell mammoth and elephant ivory apart.

This activity not only has commercial implications. It also raises significant ethical and environmental concerns. That’s because it disturbs preserved ecosystems and involves the extraction of resources that have great value to paleontological science.

Laser insights

We use a non-invasive laser technique known as Raman spectroscopy to identify the origin of a piece of ivory.
The technique works by directing a laser light onto the ivory sample.
This released light scatters back with more or less energy than the initial laser light sent to the sample.

Important implications

This makes it an ideal tool for customs officials who need to make rapid decisions.
Our study was conducted on a benchtop spectrometer (a device which breaks up light by wavelength) within a laboratory.
We are working with Worldwide Wildlife Hong Kong and the Foreign and Commonwealth Development Office to develop this technique.

Rebecca Shepherd receives funding from EPSRC and the FCDO.

Migraine sufferers in England may soon be able to access preventative drug – here’s how atogepant works

Retrieved on:

Tuesday, April 23, 2024

Atogepant (brand name: Aquipta) was recently recommended by the National Institute for Health and Care Excellence (Nice) to prevent episodic and chronic migraine attacks.

Key Points:

Atogepant (brand name: Aquipta) was recently recommended by the National Institute for Health and Care Excellence (Nice) to prevent episodic and chronic migraine attacks.
The drug would be recommended to people who have at least four migraine days a month or where at least three previous preventative treatments have failed.
Migraine is a complex neurological condition that affects about 10 million people in the UK.
It’s characterised by recurrent, severe headaches that can be made worse by physical activity and are often debilitating.
However, it’s only suited to patients who suffer from episodic migraines – whereas atogepant can be used by people who have both chronic and episodic migraines.

Consistently effective

Three clinical trials have shown atogepant to be safe and effective for people with episodic or chronic migraines.

The Advance trial evaluated how safe and effective different doses of atogepant were compared with a placebo in preventing episodic migraine.
The 60mg once-daily tablet was found to be well tolerated and effective, leading to nearly seven fewer migraine days per month.
A third trial, the 302-LTS trial, followed participants who suffered from episodic migraine for over a year, finding that atogepant was consistently effective for reducing migraine attacks.
Atogenpant was consistently shown to be safe across all studies, including the one that lasted for a year.

Anna Andreou receives funding from the Medical Research Foundation and Brain Research UK. She also received research funding from eNeura, AbbVie and Pfizer. She is affiliated with the International Headache Society, being elected as a Trustee of the Board. She is Chair of the Headache special interest group of the British Pain Society.

Newly uncovered Helen of Troy fresco shows Pompeii’s elite were eager for ancient Greek stories about women

Retrieved on:

Thursday, April 18, 2024

Face, Bread, Noise, Apollo, Younger, Clytemnestra, Curse, Darkness, Painting, Light, Foot, Human, House of the Vettii, Nature, House, Woman, Wine, Rape, Sunlight, Silence, Ship

Imagine seeing the face of Helen of Troy staring back at you, from within the ashes of a 2,000-year-old city.

Key Points:

Imagine seeing the face of Helen of Troy staring back at you, from within the ashes of a 2,000-year-old city.
And these ashes aren’t the scars of a city burned down for the sake of “the face that launch’d a thousand ships”.
Helen is depicted in stunning detail (alongside Paris, the prince of Troy) in one of the paintings on the recently discovered fresco wall of the winter dining room of a Pompeian villa.
Read more:
Pompeii’s House of the Vettii reopens: a reminder that Roman sexuality was far more complex than simply gay or straight

The women of Troy

It’s not just their unusual style, which shows the painters experimenting with new techniques and representing the latest artistic fashions.
It’s the trio of women from Greek myth collected together in a way that makes us see the Trojan war myth anew – and puts the stories of women at the forefront.
It shows that, just like us, Pompeii’s elite were well versed in – and eager for – stories of the women of ancient Greek myth.

The role of the fresco

Sit on one side, and you’d be faced with the image of Helen’s very first encounter with Paris.
Is there a sense that Helen is lingering, uncertain, with that back foot scraping behind her?
You can just imagine the Pompeian literati quaffing glasses of expensive wine as they gazed at Helen’s face and debated the subject.
This is the price of ownership over your body as a woman in Greek myth – the loss of your voice.
As the grim skeletons discovered in the villa show, just like the Trojans, Verus and his guests didn’t listen to Cassandra either.

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Emily Hauser does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Hard work and happy accidents: why do so many of us prefer ‘difficult’ analogue technology?

Retrieved on:

Thursday, April 18, 2024

Up two flights of stairs, the music machinery on offer includes brands such as Moog and Buchla, as well as modern euro-racks.

Key Points:

Up two flights of stairs, the music machinery on offer includes brands such as Moog and Buchla, as well as modern euro-racks.
(From Michael’s fieldnotes)
I finally locate the legendary Schneiders Buero, a shop selling analogue synthesizers in Berlin’s Kotti neighbourhood.
Up two flights of stairs, the music machinery on offer includes brands such as Moog and Buchla, as well as modern euro-racks.
(From Michael’s fieldnotes) As academics who rarely go a day without playing or making music, we have spent the past decade examining the extraordinary revival of analogue technology.
This means there are now more analogue options available than at any time since the 1970s, the heyday of the modular format.

The appeal of the slow

So we dived in.
Eventually, these forays became our formal research project, which has included visiting record fairs and conventions around the world, going on photowalks and attending listening evenings, and meeting an array of diehard analogue communities both on and off line.

The team is working with academics from different backgrounds who have been engaged in projects aimed at tackling societal and scientific challenges.
And we expect interest in such experiences to rise exponentially in coming years.
Recognising our existential need to occasionally slow down can be the basis for winning consumer strategies.
Recognising our existential need to occasionally slow down can be the basis for winning consumer strategies.

Saved from demolition

Rather than nostalgia, they are turning to film because of its aesthetic values and a greater sense of creative control over their photos.
In response, venerable brands including Kodak, Polaroid and Leica have re-emerged – in some cases, almost from the dead.
We literally saved it from demolition at the very last second in 2008.
We literally saved it from demolition at the very last second in 2008.
He said luxury brands such as Gucci are particularly keen on using film photography as this gives their promotional material a different look.

Work, effort, meaning

When it was conceded that digital probably was better for wildlife photography, James cut in:
That’s to miss the point!
The sound might be better but you miss seeing the work that went into the performance, the effort of the players and their crew.
Work, effort, meaning – these ideas are all interconnected for users and consumers of analogue technology.
However, when asked to compare the two, they talk about the greater weight and meaning they give to their analogue experiences.
I think it is the quality of the human voice; it does feel more like someone’s speaking to me.

And part of what makes this possible is the process of analogue recording, in which all the sounds being made, including the unscripted noise of the recording process itself, are captured in the final track.
To facilitate this sound, some musicians have even started setting up their own pressing plants, such as Jack White’s Third Man Pressing in Detroit.

The joy of happy accidents

Half of what you do trying to make music is like a happy accident that ends up sounding better than what you intended.
When we started, we didn’t have that technology, so we made mistakes and some of them were happy accidents, resulting in iconic tracks.
When we started, we didn’t have that technology, so we made mistakes and some of them were happy accidents, resulting in iconic tracks.
It’s these happy accidents that we love.
It’s these happy accidents that we love.
For example, the opening bass part of Cannonball, the 1993 song by US Indie band the Breeders, accidentally starts in a different key.
Bass player Josephine Wiggs began playing the riff one step down, then fixed it when the drums came in.

Digital technology is de-skilling us

Over the decade or so of our research, explanations for the analogue revival have shifted from nostalgia, to the desire for something physical in a digital age, to the sense that analogue technology is creatively preferable.
Is digital technology de-skilling consumers, leading to a sense of alienation?
Using analogue technology is another way consumers can feed this desire to re-skill.
Rob told us how his love of music had turned sour with the “sheer ease” of digital, starting with CDs and the MP3 player – and how vinyl had reinvigorated him.
For him, the problem came when listening on digital devices without the “sides” of vinyl albums, and then on music streaming platforms whose digital algorithms preference popular tracks.

‘This song sucks’

These are the people who want to stretch and break the rules and trigger the happy accidents that create something altogether new.
For example, photographers who seek more creative expressions by pre-soaking or “souping” their camera film in lemon juice, coffee, beer, or even burning it.
And among this group, connecting digital and analogue technology is also common – combining two completely different systems to generate even more possibilities.
Film director Denis Villeneuve’s first instalment of Dune (2021) was initially shot on digital, then transferred to film, before being re-digitised.
By combining the two, Villeneuve got a film that, in his words, has a “more timeless, painterly feel”.

For you: more from our Insights series:
How music heals us, even when it’s sad – by a neuroscientist leading a new study of musical therapy

The artist formerly known as Camille – Prince’s lost album ‘comes out’

Beatrix Potter’s famous tales are rooted in stories told by enslaved Africans – but she was very quiet about their origins

To hear about new Insights articles, join the hundreds of thousands of people who value The Conversation’s evidence-based news. Subscribe to our newsletter.
The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

How a teenager helped identify a new species of giant marine reptile

Retrieved on:

Thursday, April 18, 2024

Histology, Swimming, Ruby, Light, Research, PLOS One, University, Hope, Death, Shastasauridae, Carbon, Skull, Skeleton

A strange and enormous jawbone was discovered on the English coastline eight years ago, but my team was hesitant to identify it as a new species until more specimens came to light.

Key Points:

A strange and enormous jawbone was discovered on the English coastline eight years ago, but my team was hesitant to identify it as a new species until more specimens came to light.
Now, with the discovery of a second giant jawbone several years later, we have named a new species of ichthyosaur, an ancient marine reptile.
In 2016, prolific fossil hunter Paul de la Salle, unearthed a giant jawbone on the beach at Lilstock in Somerset.
My team, including De la Salle, studied this discovery and published our findings in 2018 in the journal PLOS One.

The preservation and fine detail provided new information that also helped us to better reinterpret De la Salle’s original bone.
We therefore erected a new genus (taxonomic rank) and species of giant ichthyosaur that we called Ichthyotitan severnensis, meaning “giant fish lizard of the Severn”.

Blue whale-sized giants

Using a basic formula called a simple scaling factor, we can estimate that our ichthyosaur was up to 26 metres long, about the size of a blue whale.
Comparisons with the same bone in other ichthyosaurs suggests that Ichthyotitan was between 20 and 26 metres in length.
We have to be careful with such estimations due to differences among species, such as those with long or short snouts.
At 202 million years old, the fossils narrowly predate a global extinction event that eradicated these giants – and marine reptiles would never reach such a size again.

Anyone can make a contribution

I asked them whether they would like to join my team to study this fossil and they agreed.
Ruby Reynolds is now a published scientist who not only found but also helped to name a gigantic prehistoric reptile.
Palaeontology is one of those sciences where anybody can make a significant contribution.

Dean Lomax worked with Paul de la Salle, Marcello Perillo, Justin and Ruby Reynolds and Jimmy Waldron of the Dinosaurs Will Always Be Awesome Museum on the referenced research. He dedicates the work to Paul de la Salle who found the first surangular in 2016.

Understanding AI outputs: study shows pro-western cultural bias in the way AI decisions are explained

Retrieved on:

Thursday, April 18, 2024

Diagnosis, Intelligence, Risk, Headache, Citizenship, Human, Light, Research, Artificial intelligence, AI, Systematic review, Norm (mathematics), Fever, Literature, European, Medical device

If you were affected, you might want an explanation of why an AI system produced the decision it did.

Key Points:

If you were affected, you might want an explanation of why an AI system produced the decision it did.
Yet AI systems are often so computationally complex that not even their designers fully know how the decisions were produced.
Explainable AI systems help AI engineers to monitor and correct their models’ processing.
We wanted to see to what extent researchers indicated awareness of cultural variations that were potentially relevant for designing satisfactory explainable AI.

Cultural differences in explanations

The other is externalist, citing factors like social norms, rules, or other factors that are outside the person.
However, such explanations are not obviously preferred over externalist explanations in “collectivist” societies, such as those commonly found across Africa or south Asia, where people often view themselves as interdependent.
If people from different cultures prefer different kinds of explanations, this matters for designing inclusive systems of explainable AI.
Our research, however, suggests that XAI developers are not sensitive to potential cultural differences in explanation preferences.

Overlooking cultural differences

Moreover, when we checked the cultural background of the people tested in the studies, we found 48.1% of the studies did not report on cultural background at all.
This suggests that researchers did not consider cultural background to be a factor that could influence the generalisability of results.
Of those that did report on cultural background, 81.3% only sampled western, industrialised, educated, rich and democratic populations.
Yet, out of the studies that reported on cultural background, 70.1% extended their conclusions beyond the study population – to users, people, humans in general – and most studies did not contain evidence of reflection on cultural similarity.

Why the results matter

To address this cultural bias in XAI, developers and psychologists should collaborate to test for relevant cultural differences.
As AI is being used worldwide to make important decisions, systems must provide explanations that people from different cultures find acceptable.
As it stands, large populations who could benefit from the potential of explainable AI risk being overlooked in XAI research.

The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

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

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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.
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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

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Table 4.2.1.
The last doses delivered by
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EMA/CHMP/20607/2024

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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.
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264

4.2.2.8.
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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

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EMA/CHMP/20607/2024

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Table 4.2.2.
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EMA/CHMP/20607/2024
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510

4.2.5.4.
The proposed specification limits should take into account the shelf-life performance of the
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EMA/CHMP/20607/2024
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medicinal product.
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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.
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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.
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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

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Table 5.2.1.
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728

5.2.2.2.
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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.
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849

5.5.
866
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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).
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EMA/CHMP/20607/2024
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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
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Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on:

Thursday, April 18, 2024

Reproduction, SCOPE, Eating, Pesticide, Convention, Change control, Confusion, Alkaloid, Climate, Fungus, Directive (European Union), Ethylene oxide, Wind, Wood, Glass, European Medicines Agency, HMPS, QDG, Hygiene, Water, Marketing, Fertilizer, Legislation, Manure, Distillation, Risk, Education, Committee, Compost, Draft, Policy, Person, EMA, Seed, Polycyclic aromatic hydrocarbon, Collection, Freezing, GMP, Risk assessment, GACP, Sunlight, Fermentation, Personal protective equipment, Animal, Herbal, Herbicide, Weather, INTRODUCTION, Documentation, Regeneration, Decontamination, EudraLex, Disease, International trade, European Pharmacopoeia, Part, Livestock, Public, Inhalation, Knowledge, Seedling, Factorization of polynomials, Record, Plant, Skin, API, Irrigation, Part Two, Soil, Directive, Pharmacopoeia, Codex, Guideline, Temperature, Attention, Hydrocarbon, Pyrrolizidine alkaloid, Polychlorinated biphenyl, Growth, Rotation, Incineration, Environment, Humidity, Smell, Ventilation, Light, Bird, Mineral, Fumigation, Pyrrolizidine, SOP, Housing, Smoking, Atmosphere, Postharvest, Rain, Liver, QWP, Medicinal plants

REFERENCES ....................................................................................................................................... 14

Key Points:

REFERENCES ....................................................................................................................................... 14
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Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

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EXECUTIVE SUMMARY

31
32
33
34
35
36

This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

37

1.
Due to the inherent
complexity of medicinal plants and herbal substances the quality of these starting materials requires an
adequate quality assurance system for the collection and/or cultivation, harvest, and primary
processing.
(either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
types could have several problems and advantages.
The used cultivation method may be dependent on
the final application of the herbal medicinal product.
primary processing of herbal substances that are used for the preparation of herbal medicinal products.
medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
stages of cultivation, collection, processing and storage.
their preparations are exposed to a large number of environmental contaminants of both biotic and
abiotic origin.
to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
Endangered species of Wild Fauna and Flora).
https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
3
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4.
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148
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8.
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7.
Where possible, stable varieties and cultivars naturally
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228

resistant or tolerant to disease should preferably be used.
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269
270
271
272
273

The application should be carried out only by qualified staff using approved equipment.
The following should be noted:
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310

?

311
312
313

?

314
315
316
317

?

318
319
320

?

321
322

?

323
324
325

?

326
327
328

?

Damaged plants or plant parts need to be excluded or limited in accordance with a specific
pharmacopoeia monograph, where relevant.
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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347
348

directly to the sun (except in cases where there is a specific need) and must be protected from
rainfall, insect infestation, etc.
The label must be clear, permanently fixed and made from
6

Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 12/14

386
387

non-toxic material.
Certain exudates that have not been subjected to a specific treatment are
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005

Page 13/14

425
426
427

also considered to be herbal substances.
European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433
Are obtained by subjecting herbal substances to treatments such as
extraction, distillation, expression, fractionation, purification, concentration
or fermentation.

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

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Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Key Points:

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive