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  1. www.fda.gov › media › 169689Navigating the First ICH Generic Drug Draft Guideline - U.S. Food...

    ICH Reflection Paper on “Further Opportunities for Harmonisation of Standards for Generic Drugs” (endorsed by ICH in Nov 2018) outlines a strategic approach for developing and enhancing ICH...

  2. www.sciencedirect.com › book › 9780128144237Dosage Form Design Considerations - ScienceDirect

    Examines the history and recent developments in drug dosage forms for pharmaceutical sciences; Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism

  3. www.sciencedirect.com › science › articleDesign space and critical points in solid dosage forms

    1 Δεκ 2017 · In order to reduce the variability of most pharmaceutical processes, the FDA developed the guidance for industry: process analytical technology (PAT), a framework for innovative pharmaceutical development, manufacturing, and quality assurance.

  4. www.sciencedirect.com › science › articleIntroduction to different types of dosage forms and commonly used...

    1 Ιαν 2024 · Dosage forms are pharmaceutical formulations containing a single or combination of pharmacologically active ingredients along with suitable additives at the desired ratio.

  5. books.google.com › books › aboutDosage Form Design Considerations: Volume I - Google Books

    28 Ιουλ 2018 · - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism -...

  6. pmc.ncbi.nlm.nih.gov › articles › PMC8592517A framework to guide dose & regimen strategy for clinical drug...

    The dose finding framework is a simple tool to help teams establish a common ground of knowns and unknowns about a drug, the disease and target population (s) and the wider development context, and for mapping this knowledge onto viable strategies.

  7. link.springer.com › chapter › 10Preformulation in Drug Product Design | SpringerLink

    17 Φεβ 2024 · This chapter provides an overview of the factors that are considered in dosage form design, including physicochemical properties of drugs, drug solubility and dissolution, drug bioavailability, membrane permeability, and solid-state characteristics.

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