Drug Pipeline Flashcards
What is a drug pipeline
A drug pipeline is a set of drugs candidates that a pharmaceutical company has on trial or development at any given time
What are the four stages of the drug development pipeline?
1) discovery
2) pre- clinical
3) clinical trials
4) marketing
What is the discovery phase in the drug pipeline?
Involves the selection of the candidate molecules on the basis of their pharmaceutical properties.
What is the preclinical stage
A wide variety of non human studies. Toxicity, pharmokinetics, formulation of the drug.
What is the clinical development stage in the drug pipeline?
Select compounds is tested for efficacy, side effects and potential dangers.
The clinical development of a drug has how many stages?
4.
In phase 1 of the clinical development
Pharmokinetics, tolerability, side effects, in healthy volunteers
Phase 2 in clinical trial
Small scale trials in patients suffering from the disease
Phase 3
Large scaled controlled clinical trials,
The during of the clinical trials
5-7 years
The during of the pre clinical trial?
1.5 years
During of the marketing
1 years
Therapeutic index
indicates how safe a drug is to be used at a low dose.
Examples of target
Receptors, ion channels, enzymes, transporters.
How would you determine the functional activity of a protein target?
Assay system
Combinational chemistry
A method of reacting a small number of chemicals to produce simultaneously a large umber of compound
Does high molecular weight, excessive polarity and possession lead to toxity?
Yes
Can natural products be used to discover leading drugs
Yes
Penicillin comes from …….
A fungi
Vincristine derives from
A plant
List advantages of using natural products
Microorganisms are diverse and easy to collect and grow.
Disadvantages of using natural products
Often complex and hard to synthesis or modify
What is lead optimization ?
Increasing the potency of the compound units drug target. Requires a lot of testing especially on small animals.
What are the main categories for testing for drugs in lead optimum
1) pharmacological testing
2) preliminary toxicology testing
3) pharmacokinetics testing
4) chemical and pharmacological development
What is pharmacological testing in lead optimization ?
Determining if the compound has obvious acute effects, such as bronchioconstrictions, cardiac dysrhythmias, change in BP, ataxia
What is preliminary toxicological testing?
To eliminate genotoxicity and to determine a non toxic dose. Checking for gross features such as weightless as well as histological and biochemically features
What is genotoxity?
genotoxicity describes a deleterious action on a cell’s genetic material affecting its integrity
Pharmokinetics testing in lead optimization.
Absorption, distribution, excretion ( metabolism and Elimination)
Chemical and pharmacological development
Assess the feasibility of large scale synthesis and purification
assess stability of compounds under conditions
develop a formulation for clinical trials
Clinical trials
Long term toxicity studies may be used
Fertility and fetal development
Phase I of clinical trials.
80- 100 healthy volunteers
Checking the pharmokinetics properties
Pharmocdynamics effects
To determine safety on the heart, kidney etc
Phase ii of clinical trials
100- 300 patients
Efficacy
Establish dose in phase iii
Involves studies which includes a wide range of disorders
Phase III of clinical trial
1000- 3000 patients Comparison of the new drugs with alternatives Pharmoeconiomics Detail of the patient group Data collection Statistical analysis Documentation Regulatory agents are introduced for licensing of the drug.
Phase IV of clinical phase
Involves marketing surveillance to determine rare long term adverse effects. This may be limited to persons withdrawing
Thalidomide
A drug given in the 1960 to pregnant women who had morning sicknesses. The children who born with birth defects especially in the limbs
