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1. Overview of Pharmaceutical Product Development. Anthony Taylor. Overview of Pharmaceutical Product Development. Objective; To achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality.

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overview of pharmaceutical product development
Overview of Pharmaceutical Product Development

Objective;

  • To achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality.
overview of pharmaceutical product development1
Overview of Pharmaceutical Product Development
  • Development of the Drug Product
  • Development of a Manufacturing Process
  • Development of Product Controls
      • Specifications
      • Test methodology
      • Stability testing
  • Support to the Development process
      • Preclinical/clinical pharmacology
  • Manufacture and Supply of Investigational Medicinal Products (IMPs)
overview of pharmaceutical product development2
Overview of Pharmaceutical Product Development

Lead Optimisation

Preclinical Evaluation

Phase IIb/ Phase III studies

Post-marketing studies

Safety/ tolerability/ PoC in humans

Lead Series

Identified

Candidate

Selected

Concept

Proven

Approval

for FTIH

Product

Launched

overview of pharmaceutical product development3
Overview of Pharmaceutical Product Development

Lead Optimisation

Preclinical Evaluation

Safety/ tolerability/ PoC in humans

Phase IIb/ Phase III studies

Post-marketing studies

Lead Series

Identified

Candidate

Selected

Approval

for FTIH

Concept

Proven

Product

Launched

Preformulation & developability assessment

preformulation and developability assessment
Preformulation and Developability Assessment
  • Purpose
      • Determination of fundamental physical and chemical properties of the drug molecule
      • Identifies potential dosage forms
      • Identifies potential issues in the development of dosage forms
    • Assessment of likelihood of being able to turn drug into a Medicinal Product
overview of pharmaceutical product development4
Overview of Pharmaceutical Product Development

Lead Optimisation

Preclinical Evaluation

Safety/ tolerability/ PoC in humans

Phase IIb/ Phase III studies

Post-marketing studies

Product

Candidate

Approval

Concept

Lead Series

Launched

Identified

Selected

for FTIM

Proven

Preformulation & developability assessment

Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies

formulation development and testing for safety assessment
Formulation Development and Testing for Safety Assessment
  • Purpose
      • Facilitate dosing in safety assessment studies
      • Ensure quality of test material
  • Issues
      • High exposures
      • Limited drug supply
      • Consistency with clinical products
formulation development for clinical pharmacology clinical studies
Formulation Development for Clinical Pharmacology & Clinical Studies
  • Purpose
      • Facilitate unequivocal testing in humans
      • Ensure quality of test material
  • Issues
      • Simple, flexible dosage form required early on
      • Limited drug supply
      • Consistency with final product
overview of pharmaceutical product development5
Overview of Pharmaceutical Product Development

Lead Optimisation

Preclinical Evaluation

Safety/ tolerability/ PoC in humans

Phase IIb/ Phase III studies

Post-marketing studies

Product

Candidate

Approval

Lead Series

Concept

Launched

Identified

Selected

for FTIM

Proven

Preformulation & developability assessment

Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies

Formulation development for market

formulation development for market
Formulation Development for Market
  • Purpose
      • Design of optimal dosage form
      • Assurance of safety & quality
      • Demonstration of consistency of performance
  • Issues
      • Dose may be unknown
      • Feedback from Clin Pharm studies required
      • Drug substance may change
      • Timing of introduction (Phase IIb, Phase III, Launch?)
overview of pharmaceutical product development6
Overview of Pharmaceutical Product Development

Lead Optimisation

Preclinical Evaluation

Safety/ tolerability/ PoC in humans

Phase IIb/ Phase III studies

Post-marketing studies

Product

Candidate

Approval

Lead Series

Concept

Launched

Identified

Selected

for FTIM

Proven

Preformulation & developability assessment

Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies

Formulation development for market

Manufacturing Process Development

manufacturing process development
Manufacturing Process Development
  • Purpose
      • Develop and validate commercial manufacturing process
  • Issues
      • Product must be equivalent to Phase III product
      • Manufacturing site
      • Product volumes
      • Drug substance may change
overview of pharmaceutical product development7
Overview of Pharmaceutical Product Development

Lead Optimisation

Preclinical Evaluation

Safety/ tolerability/ PoC in humans

Phase IIb/ Phase III studies

Post-marketing studies

Product

Candidate

Approval

Lead Series

Concept

Launched

Identified

Selected

for FTIM

Proven

Preformulation & developability assessment

Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies

Formulation development for market

Manufacturing Process Development

Product Line extensions

product line extension development
Product Line Extension Development
  • Purpose
      • Improve therapy (efficacy and/or safety)
      • Support additional indications
      • Patient convenience
overview of pharmaceutical product development8
Overview of Pharmaceutical Product Development

Lead Optimisation

Preclinical Evaluation

Safety/ tolerability/ PoC in humans

Phase IIb/ Phase III studies

Post-marketing studies

Product

Candidate

Approval

Lead Series

Concept

Launched

Identified

Selected

for FTIM

Proven

Preformulation & developability assessment

Formulation development for Safety assessment and Clinical Pharmacology/Clinical Studies

Formulation development for market

Manufacturing Process Development

Product Line extensions

Product Control - Specifications, Method development, Testing

overview of pharmaceutical product development9
Overview of Pharmaceutical Product Development
  • Product Control - Specifications, Method Development and Testing
    • Purpose
      • Define standards for safety, efficacy and quality of product
      • Assurance of product quality for preclinical, clinical and marketed product, i.e. at all stages of development
overview of pharmaceutical product development10
Overview of Pharmaceutical Product Development
  • Summary;
  • To turn a drugsubstance into a viable medicinal product which delivers the drug to the right place at the right time in the right quantity to exert the desired effect

by….

overview of pharmaceutical product development11
Overview of Pharmaceutical Product Development
  • Ensuring that the drug product is sufficiently stable that it reproducibly and reliably affects the desired pharmacological response
          • no loss of activity
          • no loss of performance
          • no increase in side effects
overview of pharmaceutical product development12
Overview of Pharmaceutical Product Development
  • Ensuring that the manufacturing process is robust, reliable and able to meet the predicted sales volumes for the product
overview of pharmaceutical product development13
Overview of Pharmaceutical Product Development
  • Developing analytical test methods to provide assurance of the quality of the medicinal product
overview of pharmaceutical product development14
Overview of Pharmaceutical Product Development
  • Commercial pressures;
    • How can we turn this drug into a medicine?

Vs

    • Can we turn this compound into the medicine we want?
  • Primarily a question of drug substance control
  • Pharmacist has many approaches for formulating “difficult” compounds
  • How difficult is development likely to be?
case study product line extension
Case StudyProduct Line extension
  • Your company markets an oral product for migraine – you are the PLE department and the commercial team have asked you to design a faster acting product.
  • The product development team is asked to ‘brainstorm’ options for this development
  • You have 20 minutes to discuss before feeding back your best concept to the Product Development Board

What do you need to know about the patient population?

What do you need to know about the disease?

What do you need to know about the properties of the drug?

What formulation technology will you use?

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