drug development processapollo
TRANSCRIPT
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Drug Development process
By
Snigdhadeb Dey
Tamara Ray
Supervisor : Dr Karabee ChatterjeeApollo Gleneagles, Kolkata
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Drugs
Broadly speaking, is any substance that, when absorbed into the body of aliving organism, alters normal bodily function.
In pharmacology, a drug is "a chemical substance used in the treatment,
cure, prevention, or diagnosis of disease or used to otherwise enhance
physical or mental well-being. Drugs may be prescribed for a limitedduration, or on a regular basis for chronic disorders.
http://en.wikipedia.org/wiki/Pharmacologyhttp://en.wikipedia.org/wiki/Chemicalhttp://en.wikipedia.org/wiki/Chronic_(medicine)http://en.wikipedia.org/wiki/Chronic_(medicine)http://en.wikipedia.org/wiki/Chemicalhttp://en.wikipedia.org/wiki/Pharmacology -
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Drug Development
In a nutshell
Drug
Discovery
Pre-Clinical
Animal Testing
Human Clinical Trials
Approval
Process
Post Marketing
Surveillance
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Drug Discovery
Program selection-
Identification of the problem-disease
A single continuous layer of flat-to-cubodial mesothelial cells covering the ovary is
considered to be the tissue of origin of EOCs
(Epithelial Ovarian cancer)
OSE EOC?
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LEAD
Lead is a compound which from a series ofcompounds have some desirable biologicalactivity
First foothold of the drug Compound library- collection of compounds,
variety or diversity of the compounds will vary
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Discovery- Lead,Compound Library, Combichem
pGlu
His
Ser
Tyr(His)
Gly
Leu(Trp)
Arg(Tyr)
Pro
Gly-NH
Trp
Lead optimization
Compound
library
Combichem
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Preclinical Testing
In-vitro cell studies
Cell migration assays
In-vivo drug validation studies
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depending on the
design, technology, and performance of your device, we may recommend additional pre-clinical
evaluation.
A. Test ProtocolsWe recommend the test protocol describe clearly defined test objectives and a rationale in
support of your belief that the endpoints and pass/fail criteria are meaningful and clinically
relevant.
B. Test Methods and ConditionsWe recommend you provide a clear description of the test methodology and actual test
conditions. We recommend you conduct pre-clinical testing, where appropriate and feasible,
in an environment that simulates actual clinical conditions.
C. Actual Device EvaluatedWe recommend you indicate whether you used a neurothrombectomy device fabricated by
representative manufacturing process. Otherwise, we recommend you submit a rationale
explaining your belief that the device you used in testing will provide a sufficient assessmentof the final finished device.
D. Statistical AnalysisWe recommend you provide your sample size justification. We recommend the results you
report include, where appropriate:
number of samples
range of values
mean
standard deviation
95% confidence interval.We also recommend you provide a probability measure that is indicative of the statistical
significance of any comparisons you make to other devices or control groups.
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IND CDER offers a Pre-Investigational New Drug Application (IND) Consultation Program6 to foster early
communications between sponsors and new drug review divisions in order to provide guidance onthe data necessary to warrant IND submission.
Animal pharmacology, toxicology studies
Evidences of previous exposure/use on human
Manufacturing details
Clinical protocol and investigator information
Lets the FDA understand the level of initial exposure
Must be updated on annual basis
Amendments can be filed anytime
Sites can be contacted, timelines may become an issue
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htm -
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Human Clinical Trials
Phase IV
Post Marketing Trials
Phase III
Confirmatory
trials
Phase II
Explanatory
Trialsefficacy and safety.
Phase I
Human/Clinical Pharmacology
Immunogenic PotencyMTD
P
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Healthy volunteers(15-30)using clinical, physiologicaland biochemicalobservations. At least 2subjects should be used oneach dose.
MTD,Pharmaodynamics,
pharmacokinetics, adverse
reactions of the Study drug
Cytotoxic drugs are studied inpatients
Investigators requiresspecialized facilities for theconduction of the trials
Patient pool = homogenouspopulation selected by (