|FROM THE WORLD OF CLINICAL RESEARCH
|Year : 2012 | Volume
| Issue : 4 | Page : 148
Drug discovery and clinical trials: A poem
Medical Affairs & Safety, Karmic Lifesciences, 802, Bldg 3, Raheja Mindspace, Airoli SEZ, Airoli, Navi Mumbai, India
|Date of Web Publication||19-Nov-2012|
Medical Affairs & Safety, Karmic Lifesciences, 802, Bldg 3, Raheja Mindspace, Airoli SEZ, Airoli, Navi Mumbai
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Balachandran L. Drug discovery and clinical trials: A poem. Perspect Clin Res 2012;3:148
The human body is indeed a wonder,
Sure, you don't have to look yonder,
When its functions go asunder,
To set it right, scientists and medicos begin to ponder.
The first is the "Target Identification" phase,
Whether the target is Adenyl cyclase or Protein kinase?
At the end of the "Target Validation" phase,
The excited scientist begins work from a new base.
Begins the best drug hunting spree,
In the trees, oceans and the high seas,
They sift the target molecule free,
And decide, 'How to make the world agree?'
First is the chemical identification,
Maceration, decoction yields the "Active" ingredient in isolation,
RP-HPLC separation and Mass-directed fractionation,
Various techniques adopted for extraction and purification.
High potency, selectivity and oral bioavailability,
With little or no interaction with CYP450,
Minimal adverse effects tilt the mandate,
With high Therapeutic Index favoring a drug's fate.
Satisfied, the chemical now goes for TOX studies (Toxicological studies),
And many many cohorts of animal studies,
Some animals survive, some lose their buddies,
Bioavailability, mutagenicity and teratogenicity are some other studies.
Work now progresses to the IND application,
The FDA/DCGI checks ALL the information,
Preclinical study data, protocols and drug source and composition,
Credentials of trial physicians and drug manufacturing information.
And once the permission comes through,
Identifying the best CRO is indeed a breakthrough,
The Clinical trials now take place in a sequence,
With Sponsors, Investigators, EC and Subjects in an alliance.
Phase I assesses safe dosage range and Side effects,
Phase II further assesses "Efficacy" in Patient subjects,
Phase III confirms data from the previous phase,
The NDA application now enters the race.
The Drug regulatory authority after careful reviewing,
Approves or rejects a new drug for marketing,
If approved, the patients have a new treatment in the offing,
Soon the hitherto immortal BUG, would take a good beating.