1 overview of pharmaceutical product development
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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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1. Overview of Pharmaceutical Product Development

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1 overview of pharmaceutical product development

1. Overview of Pharmaceutical Product Development

Anthony Taylor


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?


    Product development design case study

    Product Development Design Case Study


    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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