goods manufacturing

what are the types of clinical trials

◦ Placebo-controlled
➢ A method of research in which an inactive substance (a placebo) is given to one group of
participants, while the treatment (usually a drug or vaccine) being tested is given to another
group. The results obtained in the two groups are then compared to see if the investigational
treatment is more effective than the placebo.
➢ Without a placebo group to compare against, it is not possible to know whether the treatment
itself had any effect.

◦ Comparator
➢ It is defined as an investigational or marketed product [i.e. active control] or placebo used as a
reference in a clinical trial.
➢ These studies typically focus on efficacy relative to a drug that is already on the market, rather
than a placebo

◦ Double blind
➢ A study in which neither the participants nor the experimenters know who is receiving a
particular treatment.

double blind is the best
removed all the bias from both the pt. and the trial runners

what is a clacebo controlled clinical trial?

➢ A method of research in which an inactive substance (a placebo) is given to one group of
participants, while the treatment (usually a drug or vaccine) being tested is given to another
group. The results obtained in the two groups are then compared to see if the investigational
treatment is more effective than the placebo.
➢ Without a placebo group to compare against, it is not possible to know whether the treatment
itself had any effect.

what is a comparator trial?

➢ It is defined as an investigational or marketed product [i.e. active control] or placebo used as a
reference in a clinical trial.
➢ These studies typically focus on efficacy relative to a drug that is already on the market, rather
than a placebo

what is a double blind trial

➢ A study in which neither the participants nor the experimenters know who is receiving a
particular treatment.

double blind is the best
removed all the bias from both the pt. and the trial runners

what are the stages of clinical trials?

6-7 years

phase1

safety
human trials
PK and Pd effects
doserange

Phase II
safety
efficacy
selection

Phase III
safety and efficacy

▪ What is the intent of a clinical trial?
◦ To research and collect information on a drug's dose, effectiveness and safety
in humans.
◦ Trials are undertaken with informed and consenting human subjects according
to Good Clinical Practices (GCP).
GCP provides a controlled environment where the procedures for drug
administration and the evaluation of the results are closely monitored.
▪ The phases of the clinical trials:
◦ Phase I – a small number of subjects (20 to 80-100) to assess side effects,
verify low toxicity.
◦ Phase II – 100 to 300-500 patients to determine effective dose ranges,
efficacy, other side effects.
◦ Phase III - Larger group of patients (1000 to 3000-5000) from normally
distributed population (at this step the efficacy confirmed).
◦ Phase IV – An even larger group of patients (1000 +) from normally
distributed population (at this step the drug is being marketed

how long so all 3 phases of clinical trials run?

6 to 7 years

what happens is phase 1 clinical trial?

safety
human trials
PK and Pd effects
dose range

20 to 100

◦ Phase I – a small number of subjects (20 to 80-100) to assess side effects,
verify low toxicity.

people how many people are in clinical trial phase 1?

20 to 100

what happens in phase II clinical trial

safety
efficacy
selection
100 to 500 people

◦ Phase II – 100 to 300-500 patients to determine effective dose ranges,
efficacy, other side effects.

how many people are in phase II clinical trial?

100 to 500 people

what happens in phase III clinical trial?

safety and efficacy

▪ What is the intent of a clinical trial?
◦ To research and collect information on a drug's dose, effectiveness and safety
in humans.
◦ Trials are undertaken with informed and consenting human subjects according
to Good Clinical Practices (GCP).
GCP provides a controlled environment where the procedures for drug
administration and the evaluation of the results are closely monitored.
▪ The phases of the clinical trials:
◦ Phase I – a small number of subjects (20 to 80-100) to assess side effects,
verify low toxicity.
◦ Phase II – 100 to 300-500 patients to determine effective dose ranges,
efficacy, other side effects.
◦ Phase III - Larger group of patients (1000 to 3000-5000) from normally
distributed population (at this step the efficacy confirmed).
◦ Phase IV – An even larger group of patients (1000 +) from normally
distributed population (at this step the drug is being marketed

◦ Phase III - Larger group of patients (1000 to 3000-5000) from normally
distributed population (at this step the efficacy confirmed).

how many people are in phase III clinical trial?

1000 to 5000 people

!!!! How do you know it's a drug?

1. active ingredient (API) active pharmaceutical ingredient

2. DIN drug identification number

3. lot number

4. expiry number for recalls

5. label claims medical related claims

what is the S section?

Drug substance Active ingredient or API(active pharmapsudical product

what are the Phases of drug development?

1st phase
Drug discovery and Pre-clinical studies

2nd stage
clinical studies

3rd stage
regulatory review

4th stage
Post-marketing activities

what do all manufactures in Canada run according to?

all manufactured according to the GMP Good manufacturing principals Health Canada guidelines

what is a virtural company

it’s basicaly a white lable the offic is in Canada hower the medication is manufactured in another country

what is NDS?

new drug submission in Canada

what is NDA

new drug approval (USA)

Why an antibiotic is considered a true drug

the ability to cause allergies
the Beta-lactam ring molecule part in penicillin that cause allergies.
It is an alkaloid
It's a proven known antibiotic

What is ADME

A=absorption
D=disruption where does it go
M=metabolism is it getting cut up
E=elimination where is to excreted

what qualifies a drug for a drug submission?

-clinical trials prove it’s safety and effectivness

therepudic benefit outweights the risk

what is a NDS?

new drug submission (canada)

what is contained in a NDS?

◦ Contains scientific information about the product’s safety, efficacy and
quality.
◦ Results of both the pre-clinical and clinical studies.
◦ Side effects.
◦ Details on the production of the drug.
◦ Packaging and labelling.
◦ Information about its claimed therapeutic value.
◦ Conditions for use.

what is an ANDS?

Abbreviated New Drug Submission

Generic Drug submission

An ANDS provides the necessary information for the government
agency to evaluate how safe and effective a generic drug is
compared with its brand-name equivalent.

◦ ANDS includes scientific information that shows how the generic product
performs compared with the brand name product.

◦ Provides details on the production of the generic drug, its packaging and
labelling.

◦ The generic drug must be shown to deliver the same amount of medicinal
ingredient at the same rate as the brand name product.

◦ The generic must be equally safe and effective to gain approval.

◦ Must meet the same quality standards as an NDS.