clinical trials pppt

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SATYA VARDAN
by
MPHARM (PHARMACOLOGY)
G. Pullareddy college of pharmacy
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INTRODUCTION

• Drug development phases
• Pre-phase1 activities
• Phases of clinical trials
• Regulatory approvals IND NDA

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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

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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.

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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-IIIend 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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