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Title: clinical trials pppt


1
SATYA VARDAN
by
MPHARM (PHARMACOLOGY)
G. Pullareddy college of pharmacy
2
INTRODUCTION
  • Drug development phases
  • Pre-phase1 activities
  • Phases of clinical trials
  • Regulatory approvals IND NDA

3
DEFINITION
  • Clinical trial is systemic investigation in human
    for evaluating safety efficacy of any new drug
  • Clinical test is set of test in a medical
    research
  • And drug development that generate safety and
    efficacy data for health interventions in human
    being

4
DRUG REVIEW STEPS
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  • Before one can innitiate testing in human beings
    extensive preclinical or laboratory research is
    required
  • Research usually involves years of experiments in
    animals and in human cell
  • If the stage is successful in testing sponcers
    then provides the data to the FDA requesting
  • Approval to begin testing in humans this is
    called investigational new drug application.

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  • If test is approved by FDA test in human begins .
    This is done formally through written and
    approved protocol

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Phase 0 study/microdosing-
  • Study of new drug to derive the Pk information in
    human before undertaking phase1 studies is called
    phase0
  • MICRO DOSE-LESS THAN 1/100 of dose of test
    substance calculated to produce pharmacological
    effect with max dose lt 100 micrograms.

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  • Micro dose is early approach to demonstrate
  • the pharmacokinetic and dynamic properties of
    potential drug in humans
  • Micro dosing approach could accelerate drug
    development without compromising clinical safety
  • Micro dosing helps the researcher select better
  • drug candidates for clinical trials by providing
  • early human pk and bioavailability data.

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Advantages
  • Less chance of adverse effect
  • Short duration
  • Less no of volunteers
  • Reduced cost of development
  • Reduced drug development time
  • Limitations
  • study mainly based on safety pk matters
  • Laboratories parameters are very limited and
    expensive researchers have to depend on BA/BE
    studys.

16
Phase-1
  • First stage of testing in humans subjects
  • Designed to assess the safety, tolerability,
    dynamic and kinetic actions of drug.
  • 20-25 healthy volunteers
  • Patients - anticancer or HIV drugs

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  • Aim of phase 1 trail is to determine the maximum
    tolerated dose of new treatment
  • Maximum tolerated dose can be found by escalating
    treatment dose till dose limit toxicity
    reached(DLT)
  • Kinds of phase 1
  • SAD- SINGLE ASCENDING DOSE
  • MAD-MULTIPLE ASCENDING DOSE
  • FOOD EFFECT-it differs the drug absorption with
    food

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Limitations of phase-1
  • Trial restricted to homogenous subjects
  • Performances extrapolated to heterogeneous
  • Market place

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Phase -2
  • Therapeutic exploratory trial.
  • 20-300 subjects
  • To confirm effectiveness, monitor the side
    effects evaluate further safety
  • First in patients who have disease that the drug
    is expected to treat

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Phase II study
  • Phase II types
  • Phase IIA -designed to assess dosing
    requirements
  • Phase IIB- designed to study efficacy

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Phase-III
  • Therapeutic confirmatory trials
  • Large scale , multi center, randomised controlled
    studies
  • Target population is about 100-3000 patients
  • Time is about -5years

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Phase-III types
  • Phase IIIA-to get sufficient and significant
    data.
  • Phase IIIB-it allows patient to continue to
    treatment, label expansion additional safety data
  • Label expansion is nothing but additional cure of
    disease beyond the label or original use

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Phase-III end of clinical trials
  • Expert committee review the safety and efficacy
    and profit on potential sales
  • Go-no-go decision to file a new application with
    DCGI.
  • Expert review by DCGI COMMITTEE
  • After DCGI committee
  • NCE markated then Phase-IV begins

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Phase-IV
  • This is done after drug has been markated
  • PMS(post marketing survivalence)
  • No fixed duration/patient population
  • Studies continue to collect the data about
  • effects in various population side effectsfrom
    long term usage

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Phase-IV
  • This helps to detect the long term and rare
  • ADR effects
  • And also explore new use of drugs
  • PERIODIC SAFETY UPDATES
  • To be submitted by the manufacturer to FDA every
    6months for 2 year in b/w this period if no ADRS
    found then the drug will be approved for
    marketing

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Phase-IV objectives
  • Evaluation in different age groups/types of
    patients
  • Comparative benefit risk assesment
  • Drug usage in the community
  • Quality assesment

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REPORTING OF ADR
  • After collecting the report from different areas
  • The report must be submitted to following
    departments
  • WHO-INTERNATIONAL SYSTEM
  • USFDA-MED WATCH
  • UK YELLOW CARD SYSTEM
  • INDIA-NATIONAL PARMACOVIILANCE PROGRAME(CDSCO)

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  • REFERENCE
  • From text book of hospital clinical pharmacy by
    .S balasubramanyamanian.
  • . N.narayanan

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