Drug development and animal experminting #weekly_question40

Ohio the new hi

*Lately, I've been, I've been thinking

I want you to be happier, I want you to be happier

I think that we both know the way that this story ends

Then only for a minute

I want to change my mind

'Cause this just don't feel right to me

I wanna raise your spirits

I want to see you smile but

Know that means I'll have to...*

Oh! You readers are here already.

Hahaha i was singing along with happier by Marshmello

It was hard on me the last week, seeing my friend acting normal with all but cold with me made me stressed a lil.

I thought a million thought and one on how can we

Though tbh am acting dramatically, i used to write a lot of stories thats why i tend to live my life as if living a novel

Lets continue talking later my reader now i need a dose of knowledge IV to detoxify the drama i feel hehehe

#weekly_question40

Drug development and animal experimentation

Hmmm this will be tricky first of all we need to know what's a drug, how does it work, and finally what is the procedure of drug development. After that all we can begin talking about the ethics of animal experimentation.

1- Drug definition:-

The definition of a drug is:- any chemical substance that can effect a biological system.

by a biological system i mean a living thing which can be defined as:- any entity made up from organic compounds with the solo purpose of maintaining itself

(***maintaining itself is a phrase used as an alternative for the classical view on the purpose of life, it states that the reason of living is to maintain the system, the system has two main characteristics, always changing and self-developing)

Then we need to identify the pharmacological profile of a drug i.e the dynamics and kinetics that rule the relationship between a drug and its effect and the proper dose.

2- pharmacodynamics:-

Hmmm, let's talk about what do we mean by effect, there are a three ways a drug can affect a biological system:-

A- physical action:- to induce a change in the system due to its physical probabilities e.g. diuretics increase osmolarity which leads to increase in renal elimination (i.e kidney elimination)

B- chemical action:- to induce a change directly due to a simple chemical reaction e.g. antacids neutralize gastric acidity by a base.

Finally the really controller of the drug-body interactions ligand-receptor actions

C- ligand-receptor actions or interactions:- this need a lil more details cuz it is the major way drugs induce their effect

I- all of the functions a biological system make to maintain itself is facilitated by proteins and similar compounds

2- the synthesis, utilization, secretion & even degradation of proteins is done by the cell and controlled by extracellular signals called liginds

3- liginds are small molecules that can bind to special proteins on the surface of the cell or inside it called receptors

4- this binding will result in a conformational change in the receptor structure leading to a cascade of events that will terminate in a biological change

5- types of ligands:-

A- agonist:- any molecule that can bind and activate the receptor

B- antagonist:- any molecule that effects, mostly a negative effect, the relationship between the agonist and its biological response

6- most of drugs are basically liginds

***in all three ways the drug response is proportional to the dose or amount of drug given

Yep! This all is what we call pharmacodynamics, to summarize it we can say that it is the study of drugs' effect on the body or graded dose-response relationship.

Pharmacodynamics has another objective which is to demographically or statically study the relationship between a drug and its action called quantal dose-relationship

In this part of pharmacodynamics three concepts must be defined and identified:-

A- median-effective dose (ED50):- the amount of dose where 50% of population are effected

B- median toxic dose (TD50):- the amount of dose 50% of population had toxic side effects (the population here is made up from animals)

C- media lethal dose (LD50):- the amount of dose 50% of population is dead (the population is from animals)

Why must we know them? For the reason to find:-

A- therapeutic window:- the dose where only effect appear

B- therapeutic index:- a parameter that is used to know the extent of difference between ED50 & TD50, the higher the better the safer

C- safety margin:- the difference between ED50 & LD50

In conclusion the aim of pharmacodynamics is o study the mechanism of how the drug affects the body plus the appropriate dose to be given

3- pharmacokinetics:-

Without further ado it is the study of how the body effect the drug, this effect is manifested by the four following concepts:-

A- absorption:- the process of delivering the drug into blod-streem from the istration site, it is hugely affected by the route of istration

B- distribution:- the process of bring the drug from the plasma into the Interstitial fluid, i.e the fluid that surrounds the cells

C- metabolism:- the process of biotransforming the drug to facilitate its elimination

D- finally elimination:- the ability to irreversibly excreting the drug away from the body

Variations in these processes are the main cuz of difference in dose required for the patient and the main cuz of adverse drug reactions e.g due to elderly people having different pharmacological profile they are mor susceptible to Adverse drug reactions

4- the process of drug development:-

Two major stages are found in the process of drug development:-

A- the discovery stage:- all the laboratory processes that are inted to find a drug that can act as a ligand either agonist or antagonist (from 4-5 years of research)

B- clinical studies:- controlled experiments on humans in hospitals or clinics to evaluate a drug (from 6-10 years of studying)

Lets talk more about the clinical studies

——clinical studies:-

***The aimis:-

1- to identify the pharmacological profile of the drug on humans.

2- to identify the target patients, whom will have maximum effect and minimum adverse reaction.

3- to identify any possible adverse reactions and safety issues.

***Criteria for a good study:-

1- clear objective

2- careful protocol design

3- an adequate free from bias statical analysis

***phases:-

This stage of drug development has four main phases before the drug can be itted into the market:-

Phase(1):- pharmacological profile of drug on normal humans

A- to test a drug on a limited number of health human volunteers ~20-50 volunteers

B- aimed to study the pharmacological profile of the drug on healthy humans

Phase(2):- therapeutic exploration

A- to test the drug on a limited number of real patient (~50-300)

B- aims:-

1. To study the pharmacological profile of a drug on patients

2. To asses potential therapeutic effects

Phase(3):- the conformation

A- very important phase due to the increased confidence in using the drug

B- test on large number of patients (~250-1000 or more)

C- randomized multicentered comprehensive studies to test a drugs short term effects & safety

Phase(4):- the therapeutic use and its chronic effects

A- mostly post-marketing surveillance for a very large number of patients (~2000-10000 or more)

B- aim to study the long term effects of a drug & its safety

After finishing registration of the drug can be made, then marketing stage start

—— preclinical studies:-

Finallyyyyyyy!!!!! The main topic of our post, between the two stages there is a transitional stage which mainly is concerned with animal experiments.

5- preclinical studies & animal experimentation ethics:-

O ethics

O morality and common sense

Life and death, thoughts and actions

We are here again for a time of ethics

We shall now begin ethics

This phrase , shall now begin ethics, is brought from a manga with the same name that has a mysterious MC that sometimes feels like me. Now I feel everything he felt but I don't think I will follow his steps.

I am still beginner in the ethics thingy so sorry for my lacking

Why do we experiment on animals? Isn't it enough to experiment in isolated cells or tissues? Sigh, the problem is that our bodies are a multivariable entity, in other words it is governed by the rules of chaos theory, not common sense.

Experimenting on animals is important to know does the body works as artificial tissues, or is there a hidden variable unknown. Or to know more.

The major argument for using animals is that we eat them right? Then drug development is more important. But this isn't justifiable enough to use animals. The really argument to use is that animal testing is the best screening method for diseases.

Two counter arguments can be used

1- regulations are a must:- as you have seen in quantal-dose response when finding TD50 and LD50 we basically kill and toture the animal being experimented on.

In my world view death is only a state of rest, but pain is a different story, we can kill if inevitable and have a reason but we can't induce pain to an extent.

Someone in the crowd may ask this hard question, how do we know that animals are conscious of their suffering? Will we dont, simply cuz the definition of pain does not count in consciousness.

Pain’s definition in a physiological sense is:- the accumulation of hemostatical changes due to the activation of Somatosensory Receptors.

In other words without thinking of the soul of the animal, if the somatosensory receptors the type that responsible for delivering pain is activated then the animal dose feel pain

2- Alternative is a must:- if an alternative appears we must use it, this is a law followed by the UK, but of course not all countries follow it which is something regretful, in other words our greed musnt blind us.

In conclusion, we humans will use every means we have to survive. This is a fact that all know, but this isn't the same thing as being lazy or greedy. After all cuz we have the ability to utilize our earth, we are obligated to maintain it as a part of our living purpose.

6- will hehehehhe

Hey! Author continue your story!!! Tell us what will you do now.

Really you wanna hear mine? Ok thanks.

I simply acted sillily, and way too much dramatically

I will stop acting in a dramatic way hehehe, how hard will this be.

I really don't understand how can someone stand me, and i hope my friend will forgive me

I wont leave and never i will, more so i will control this place, i will make it my world, i won't leave cuz i'm afraid to repeat this again

Though i will stay as the elephant in the room

Hehehe this is the name of a song, all my words have a reference

Dont worry my reader i wont stop writing for you stories after all my life is a novel

So seeya next time

We shall meet at the time of knowledge