lab Drug Develpment

Drug Development&Naming

“Journey of a Drug”

From Test Tube TO Prescribing Physician

Drug Development & Naming

1-How Modern Drugs are Developed?

2-Naming of Drugs.
3-Drug Advertisement.
Drug Development & Naming

1-History.

2-Physical Examination.
3-Diffrential diagnosis.
4-Investigations.
5-Diagnosis.
6-Treatment.
7-Prognosis.
Fundamental 7 Steps of Medical Practice


Treatment is the aim of Physician and whether this was:

Medical
Surgical
Psychological

“Drugs are almost always used”

Fundamental 7 Steps of Medical Practice

Whenever a drug is prescribed:

The Skill & knowledge of Pharmacology is Exercised and Used !
Fundamental 7 Steps of Medical Practice

Three Basic Principles!

1-The drug is safe.
2-It is effective for the disease on which it was developed to treat.
3-It can be manufactured correctly and reproducibly each time.
Modern drug development


“Innovator product” passes in the following process:

1-Prediscovery stage.

2-Preclinical stage.
3-Human trials.

A process of 10-15 years.

Stages of Drug Discovery

In Summary!

Starting 5000-10,000 compounds in Prediscovery.

250 reach Preclinical stage.

5 involved in Clinical trials.

1 drug reach the Market !

Stages of drug Discovery


Drug development is a long and risky process
1.1-1.7 billion dollars

Clinical trials cost most !

Stages of drug Discovery

1-Prediscovery Stage

10,000 compounds

Preclinical goal:

1-Understand the disease what is wrong with the gene or protein.

2-Biological target identification.

3-Discovering molecules which could interact with the target.

Stages of drug Discovery

From where we get the test compounds?


1- Natural sources.

2-High Throughput Screening.(most common).

3-Computarized methods and biotechnology matching from electronic libraries.

Stages of drug Discovery

The Aim is to find out the compound which fits the target protein

ex. Enzyme

(High Throughput Robot Unit)

2-Preclinical Stage

250 compounds


Early safety evaluation
Animals rodents

In Absorption.

Through Distribution.
Out Metabolism and excretion.

Stages of drug Discovery

Final Animal Testing:

1-Acute Toxicology Studies = 2 Weeks.

“Dose of No Adverse Effect”

2-Determination of Maximum Tolerated Dose MTD = 2 Weeks

3-Long Term Toxicology = 6 Months (or more)

Stages of drug Discovery

IND application:


Investigational New Drug

IND application:

1-Animal Pharmacology & Toxicology.

2-Manufacturing Data.

Safety is a key aspect!
Stages of drug Discovery

3-Clinical Trials

5 Compounds!

Clinical trials:

Out of 250 compounds of preclinical stage.

5 reach clinical trials.

70 % of the cost of development.
Stages of drug Discovery

Basic Principles of Clinical Trials:

1-Placebo controlled trials.

2-Randomized trials.

3-Double blind trials.
Stages of drug Discovery

Basic Principle of Clinical Trials:

1-Phase one clinical trial.

2-Phase two clinical trial.

3-Phase three clinical trial.
Stages of drug Discovery


Phase One Clinical Trial

Phase one:

“Healthy volunteers”

Evaluation of safety.

One dose.
“20-100 Subjects”

6-18 months.

Stages of drug Discovery

Single dose maximum tolerable dose

40 % of tested drugs FAIL the study!

Stages of drug Discovery

Phase Two Clinical Trial


Phase 2 :

“100 – 200 patients with the disease”

To assess the efficacy of the drug
Side effects
Risks

Phase two 6 months – 3 years

“60 % of drugs fail phase 2”

Stages of drug Discovery

Phase Three Clinical Trial

Phase 3 :

“Largest 1,000-5,000 Patients”

Statistically significant data on risk & benefit

2- 4 years


40 % will fail the study!

Stages of drug Discovery

NDA Application is issued

(New Drug Application)

At this stage a:

“NEW DRUG APPLICATION IS ISSUED”

NDA

Summary of all tests

100,000 pages!

Stages of drug Discovery

NDA is reviewed within 18 months


6 different teams review the tests THEN:

Approval is Granted

Then it can be marketed immediately!

Stages of drug Discovery

Phase 4 stage:

Post marketing Surveillance

1000 s of patients
Long term risks

When severe reaction is reported the drug will be withdrawn from the market!

Stages of drug Discovery

Only two out of 10 approvals recoup the cost of development!

Is That All ? NO !


After approval a Patent is issued:

Its average time is 11 years where the Pharmaceutical company has exclusive rights to manufacture the drug.

Patent include composition and methods and synthesis.

Stages of drug Discovery

Generic drug approval

After the patent has expired any pharmaceutical company can apply for generic drug approval.

Needs Bioequivalence to the innovative drug.

Approved drug with therapeutic equivalence evaluation.

Stages of drug Discovery

Approved Generic drug is registered in the Orange book

www.fda.gov/cder/ob

Stages of drug Discovery

1-Full Chemical name. IUPAC.

International Union of Pure and Applied Chemistry.

2-rINN Recommended International non proprietary name.

(Generic Name, Official Name)

3-Properietary name (Brand Name).

Naming of drugs:

Old Names:

British Approved Name(BAN) not used after 2003.

Amoxycillin = BAN

Amoxicillin = rINN
Naming of drugs


Stands for = “Drug Making”

BP = British Pharmacopeia.

USP = United States Pharmacopeia.

Ph. Eur. = European Pharmacopoeia.

Pharmacopeia: