Target Product Profiles in Drug R&D – Regulatory Profiles

Target Product Profiles in Drug R&D – Regulatory Profiles

Regulatory Target Product Profiles (RTPPs)  RTPPs describe the aims of a drug development programme in terms of labelling concepts. They can be used by regulatory agencies to quickly see the claims the developer is aiming for with a new drug and therefore the data, experimentation and clinical trials needed to support these claims from the regulatory perspective.    An RTPP is a valuable reference document that helps the drug developer and regulatory agency understand the entire drug development process, from pre-investigational new drug application (pre-IND) through post-approval programs to pursue new labeling claims or indications. An RTPP is not a necessarily a fixed description of the aims of drug development but may change as more becomes known about the nature of the drug under development.   Possible sections of an RTPP could include:   Therapeutic area   Indications and usage   Patient population   Dosage, dosage form and administration   Claims and labelling   Clinical pharmacology   Proposed clinical programme and data to be provided   Toxicology programme and data to be provided   Contraindications and drug interactions   Adverse reactions   Warnings and...
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Target Product Profiles in Drug R&D – Emerging profiles

Target Product Profiles in Drug R&D – Emerging profiles

Emerging TPPs  As a drug moves through development its properties, activity and effect on disease are revealed. ETPPs are used to summarize these aspects for the drug given the current understanding of the drug’s performance and how they align with the critical elements of the Aspirational TPPs.   ETPPs typically describe the value critical aspects of the drug from the developer’s perspective - which may be the potential usage and uptake in patients for a commercial drug developer, or how the drug can enable access to hard to reach neglected diseases from a not-for-profit drug developer, or even how the approach may drive the science in a new area and foster innovation from a more academically focussed developer. ETPPs should cross reference the critical requirements of the ATPPs, unless the drug in question is in a new and unexpected area where no ATPP exists. Some examples of the elements of ETPPs are:   Efficacy and toleration profile   Number of hospital days saved   Sttability data for the formulation...
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Target Product Profiles in Drug R&D – Introduction

Target Product Profiles in Drug R&D – Introduction

Target Product Profiles (TPPs) are descriptions of key features needed in a new treatment for a disease and are used to guide and drive drug research and development. They can save time and aid communication with regulatory agencies, they can provide direction for drug development programmes, they can help to stop inappropriate drug development and save resources, they can point the way to the critical experiments, and they can summarize drug profiles to varying stakeholders. As we shall see, TPPs have different meaning and structure dependent on usage. Here we intend to explore and clarify.    TPPs can be broadly divided into 3 related forms:   Aspirational (ATPP). A fixed description of the essential attributes of a treatment for a disease, derived from a wide ranging understanding of the disease in question, the medical and commercial opportunity, the regulatory hurdles, any real or potential competitors, the access and re-imbursement environment, and the goals of the developing organization.   Emerging (ETPP). As the drug undergoes trials its properties are revealed. This...
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