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CLINICAL TRIALS & NDA
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CLINICAL TRIALS & NDA

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  • 1. SHAILENDRA JADIYAM.Pharm*School Of PharmaceuticalSciences, RGPV, BhopalShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 2. GOODAFTERNOON…Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 3. Introduction of The DrugDevelopment Process• Long, Costly & Complex Process• Patent – 20 years• Cost-US$1000 million(approx.) for asingle DrugShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 4. Current Methods Used in DrugDiscovery Process-1. Identification & validation ofbiological target2. Screening Large compounds &natural compounds3.Molecular modeling4.Targeted synthesis5.Combinatorial chemistryShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 5. The New Drug Development ProcessShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 6. Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 7. Clinical Development Of DrugClinical Development Plan•Money, Time, Resource & Planning.•Safety & toxicity data from pre-clinical studiesenables drug company to initiate clinical trials.•Clinical trials on patients in the differentcountries are approved & monitored by differentregulatory agencies like:ImportantInfoShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 8. 1.In India, DCGI(Drug Controller General ofIndia) office under CDSCO (Central DrugStandard Control Organization).2.In UK, MHRA(Medicines & Healthcareproducts Regulatory Agency), advised bythe CSM (Committee on Safety ofMedicines).3.In USA Food & Drug Administration(FDA ).Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 9. Phases of Clinical Trials•Phase1-(Human/ ClinicalPharmacology)•Phase2-(Exploratory Trials)•Phase3-(Confirmatory Trials)•Phase4-(Post Marketing SpecialStudies)Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 10. Phase1 Clinical Trials•Phase1 studies sometimes called ‘first in man’•Healthy volunteers•Anticancer drugs are never tested in healthyvolunteers•During Phase1, sufficient information about thedrug’s pharmacokinetics (ADME) &pharmacological effects should be obtained topermit the design of well-controlled, scientifically valid, Phase2 studiesShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 11. •Phase1 studies also evaluate drugmetabolism, SAR, MOA in humans•These are generally conducted on 20-80healthy human volunteers & typically last 3-6monthsPhase1 Trial Address:•How rapidly the drug is absorbed?•Where is the drug distributed in the body?•Which organs or organ system are involved inmetabolism of the drug?•How quickly is the drug eliminated from thebody?Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 12. FACT: only about 70% ofexperimental drugs passesPhase1 clinical trials.ImportantInfoShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 13. Phase2 Clinical Trials•These trials conduct on patients.•Small number of subjects, typically100-300•The trial may last from 6 months to 2years•“What is the most effective dosagerange & is the drug safe within thatrange?”•These trials are establish clinicalefficacyShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 14. Phase2 Trial Address:•What is the minimumeffective dose?•What is the maximumtolerated effective dose?•Is the drug effective inmild, moderate, & severecases of the disease orcondition?ImportantInfoFACT: only about 35% ofexperimental drugs passesPhase2 clinical trials Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 15. Phase3 Clinical Trials•overall benefit-risk relationship of the drug•Several hundred to several thousand patients& lasts 1-5 years•Drug’s effectiveness & any adverse reactionin a large group of patients•Phase3 trials involve different patient sub-groups such as children, the elderly•Once the phase3 clinical trial has beencompleted satisfactorily, the drug company isin a position to apply the marketing applicationto the regulatory authorities to market the drugShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 16. Phase3 Trial Address:•Overall benefit-risk relationship•Adverse reactions in a large group ofpatients over a longer period of exposure•The ideal dosage regimen•Should the drug is allowed to be marketed?FACT: only about 25% ofexperimental drugs passesphase3 clinical trialsImportantInfoShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 17. SponsorContact ResearchOrganization (CRO)Clinical StudySite InvestigatorsTrial OrganizationShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 18. New Drug Application(NDA)•All three phases of clinical trials, the companyanalyzes all of the data & files an NDA toFDA/DCGI•NDA must contain all of the scientific information•NDAs typically run 100,000 pages or more•By, law FDA is allowed 6 months to review anNDA•But 1st to final submission of an NDA approvalperiod exceeds that time•In mid-1997 ICH agreed a project CTD(commontechnical document)-3 ICH region-US, EUROPE, JAPANShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 19. Submitting an application:•Dossier Summary•Chemical, Pharmaceutical &Biological Documentation•Pharmaco-ToxicologicalDocumentation•Clinical DocumentationShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 20. Successful Application•Regulatory Authority grants a productLicense.Product Registration•Products to be marketed in UK reqireapproval from MHRA•In US- Approval from US FDA•In India- Approved by DCGIShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 21. Product Manufacture•The life of a patent for a new drug is20 years•If it takes 10-14 years to develop theproduct & clinically test it beforepermission is granted by the regulatoryauthorities to market•Once a patent has expired, othermanufacturers can produce the product(called generic version) & sell it at alower cost.Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 22. FACT: only 1 in every 3 drugswhich reach the market recoupsits development costsImportantInfoShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 23. Phase4 Clinical Trials (PostMarketing Surveillance)•Withdrawal of the drug is not uncommonoccurrence- 1960’s- Drug Thalidomide•Continuous market surveillancePhase 4 Trial Address•More about side effect & safety of thedrug•Long term risks & benefits of the drug•How well drug works when it’s usedmore widely than in clinical trialShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 24. Generic Drug ProductANDA(Abbreviated New DrugApplication)•ANDA is submitted to regulatory bodies toto obtain the approval to market a genericproduct•Generic drugs- termed as ‘abbreviated’not required preclinical(animal) &clinical (human) dataShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 25. Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 26. Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 27. Important Terms:1.ADR2.ADE3.CRF4.CRO5.GCP6.IC/ICF7.ETHICS- IRB, IEC8.PROTOCOL9.INVESTIGATOR BROCHURE10.AUDIT- QA/QC, CRA/CRC11.RANDOMIZATION Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 28. 12.SOURCE DATA-SOP, PROTOCOL13.BLINDING- Open, Single, Double14. INVESTIGATOR15.SPONSORShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 29. SPONSOR/CRO> INVESTIGATOR>IRB/IEC> CRA/CRC> REGULATORYAUTHORITY> SUBJECTSPROTOCOL> IRB> IEC>GOVT.OFFICE(DCGI)> CLINICALTRIALSShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 30. References:•FDA.GOV•Remington science•Mark MathieuShailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal
  • 31. Shailendra Jadiya (M.Pharma-QA 2012)School Of Pharmaceutical Sciences, UIT, RGPV, Bhopal