Pharmaceutical Technology Lec. 7
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Questions and Answers

What is the approximate range of costs associated with bringing a new drug to market?

  • $500,000 to $1 million
  • $1 billion to $3 billion
  • $250 million to $1 billion
  • $500 million to $2 billion (correct)

    • Biological products are primarily made from organic small molecules.

    False (B)

    What initiative aims to improve the competitive situation of the European Union in pharmaceutical research?

    Innovative Medicines Initiative

    The high failure rates in pharmaceutical development are referred to as __________ rate.

    <p>attrition</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Drug product = An organic small molecule used for therapy Biological product = Medicinal products from living sources Veterinary products = Medicinal products for animals Cosmetics = Products applied for beautification purposes</p> Signup and view all the answers

    Which of the following is NOT a category of registered products?

    <p>Nutritional supplements (D)</p> Signup and view all the answers

    Well-designed clinical trials can help decrease the attrition rate in drug development.

    <p>True (A)</p> Signup and view all the answers

    What are medicinal products commonly used for?

    <p>To diagnose, cure, or prevent diseases and disorders</p> Signup and view all the answers

    What is the purpose of the MEdDRA dictionary?

    <p>To facilitate international sharing of regulatory information (D)</p> Signup and view all the answers

    The CTD format is jurisdiction-specific for regulatory submissions.

    <p>False (B)</p> Signup and view all the answers

    What are the three major regions associated with the CTD submissions?

    <p>Europe, USA, Japan</p> Signup and view all the answers

    The implementation of CTD has led to an increase in _____________ savings.

    <p>resources</p> Signup and view all the answers

    Which organization is responsible for drug regulation in the USA?

    <p>FDA (A)</p> Signup and view all the answers

    The ICH was established to eliminate the need for any testing and reporting during drug research and development.

    <p>False (B)</p> Signup and view all the answers

    What are the three basic factors considered for approving new medicinal products?

    <p>Quality, Safety, Efficacy</p> Signup and view all the answers

    The organization known as EMA stands for _____ medicines agency.

    <p>European</p> Signup and view all the answers

    Match the following guidelines with their respective concerns:

    <p>Quality = Stability studies and impurities testing Safety = Carcinogenicity and genotoxicity Efficacy = Clinical trial conduct and reporting</p> Signup and view all the answers

    What does ICH aim to achieve in its mission?

    <p>Harmonization of technical guidelines (B)</p> Signup and view all the answers

    The relevance of impurities testing is not considered in the harmonization of quality guidelines.

    <p>False (B)</p> Signup and view all the answers

    The MHLW stands for the Ministry of Health, Labor, and _____ in Japan.

    <p>Welfare</p> Signup and view all the answers

    Which of the following is NOT part of the CTD format?

    <p>Module 6 (A)</p> Signup and view all the answers

    The CTD format should be modified as per the applicant's preference.

    <p>False (B)</p> Signup and view all the answers

    What is the purpose of Module 2 in the CTD format?

    <p>It presents the table of contents, introduction, quality overall summary, and summaries for non-clinical and clinical data.</p> Signup and view all the answers

    Module 3 of the CTD focuses on the quality of the substance and drug product, including aspects of ________ and stability.

    <p>manufacturing methods</p> Signup and view all the answers

    Match the following Modules with their primary focus:

    <p>Module 1 = Submission documents &amp; administrative info Module 3 = Quality control &amp; characteristics Module 4 = Non-clinical study reports Module 5 = Clinical study reports</p> Signup and view all the answers

    Which modules are intended to be common across jurisdictions?

    <p>Modules 2 to 5 (C)</p> Signup and view all the answers

    Consulting the responsible regulatory authority is unnecessary to determine the applicability of the CTD format for a product.

    <p>False (B)</p> Signup and view all the answers

    What document type provides a critical assessment of data in the CTD format?

    <p>Overview</p> Signup and view all the answers

    What does the active substance master file (ASMF) consist of?

    <p>The applicant's open part and the manufacturer's closed part (C)</p> Signup and view all the answers

    The applicant for a marketing authorization must always be the manufacturer of the active substance.

    <p>False (B)</p> Signup and view all the answers

    Who supplies the active substance manufacturer's restricted part to the authorities?

    <p>The active substance manufacturer</p> Signup and view all the answers

    The applicant has the responsibility to ensure that the complete ASMF is supplied to the ___.

    <p>authorities</p> Signup and view all the answers

    What is the maximum limit for the same active ingredient in the market according to the drug registration procedures?

    <p>12 (D)</p> Signup and view all the answers

    What is the main purpose of the assessment before granting a registration license?

    <p>To ensure quality, safety, and efficacy of products (B)</p> Signup and view all the answers

    The CTD format provides detailed information about the contents of a dossier.

    <p>False (B)</p> Signup and view all the answers

    Pharmaceutical products can be traded without registration if they are locally prepared.

    <p>False (B)</p> Signup and view all the answers

    What must be delivered within 3 working days after a box of approval?

    <p>Naming, Pricing, Pharmaco-vigilance report</p> Signup and view all the answers

    Match the following Central Administration departments with their functions:

    <p>Central Administration for Pharmaceutical Policies = Market support Central Department of Biological and Innovative Preparations = Clinical Studies Central Administration of Medical Supplies = Medical supplies oversight Central Administration of Pharmaceuticals = Pharmaceutical regulation</p> Signup and view all the answers

    The NFSA is responsible for the registration of ___ supplements.

    <p>Dietary</p> Signup and view all the answers

    Ministerial Decree 174/1974 enforces that products must be re-registered every _____ years.

    <p>10</p> Signup and view all the answers

    Which track submission is generally easier for imported drugs?

    <p>Imported drug register (A)</p> Signup and view all the answers

    Match each type of applicant with their corresponding role in drug registration:

    <p>Factory = Where manufacturing takes place Toll Pharmaceutical = A company with a contract for manufacturing Agent or distributor = Distributes products for another company Scientific office = Carries out advertisements for medical products</p> Signup and view all the answers

    A pilot batch manufacturing must include only 5% of the production batch.

    <p>False (B)</p> Signup and view all the answers

    What is required for the importation approval of raw materials?

    <p>Active Pharmaceutical Ingredient (API)</p> Signup and view all the answers

    Flashcards

    Drug Development Costs

    The cost of bringing a new drug to market, including capital expenses for research, development, and clinical trials.

    Attrition Rate

    The high rate at which drug candidates fail during clinical trials due to safety, efficacy, or other reasons.

    Strategies to Decrease Attrition Rate

    These are designed to reduce the attrition rate and obtain reliable data for regulatory approval. They include well-designed clinical trials focused on efficacy and safety.

    Novel Initiatives in Drug Development

    Collaboration between government and industry to accelerate drug development, like the European 'Innovative Medicines Initiative'.

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    Medicinal Products

    These include traditional drug products, like pills and tablets, and biological products derived from living organisms.

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    Biological Products

    These are medicinal products that are made from substances extracted from or produced by living organisms, such as proteins or antibodies.

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    Drug Product

    Typically a small molecule that interacts with a biological target, such as a protein, to produce a therapeutic effect.

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    Drug Registration

    The process of registering a new drug or biological product for use in humans or animals.

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    Active Substance

    The drug substance is the active ingredient in a medicine. It's the chemical that produces the desired therapeutic effect.

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    ICH

    The ICH (International Council for Harmonisation) is a group of regulatory authorities and pharmaceutical companies from Europe, Japan, and the US. Their aim is to harmonize global drug development and registration guidelines.

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    ICH's Mission

    The ICH's mission is to streamline drug development and registration processes by creating shared guidelines. This reduces duplication of testing and reporting, ensuring safe and effective medicines.

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    Safety Guidelines

    Safety guidelines focus on potential risks associated with a drug, including carcinogenicity (cancer-causing), genotoxicity (damaging DNA), and repro-toxicity (affecting reproduction).

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    Quality Guidelines

    Quality guidelines define standards for drug development and manufacturing. They include aspects like stability studies (how a drug changes over time) and setting limits for impurities.

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    Efficacy Guidelines

    Efficacy guidelines concern the design, conduct, safety, and reporting of clinical trials. These trials evaluate how well a drug works in humans compared to a placebo or currently approved treatments.

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    FDA

    The FDA is the regulatory authority for authorizing new medicines in the United States.

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    EMA

    The EMA is the European Medicines Agency, responsible for approving new medicines in the European Union.

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    MedDRA (Medical Dictionary for Regulatory Activities)

    A standardized dictionary used for describing medical terms, especially for reporting adverse events. It helps to ensure consistent naming and categorization of medical events across different countries.

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    CTD (Common Technical Document)

    A globally recognized document format for submitting applications to regulatory authorities for new medicines in the EU, USA, and Japan.

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    Pre-CTD Regulations

    Prior to the CTD, each regulatory authority had its own unique format for submitting applications. This resulted in duplication of effort and higher costs for companies who needed to submit applications to multiple countries.

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    Benefits of CTD

    The CTD has streamlined the process of applying for drug approval by promoting a unified format for applications. This reduces unnecessary duplication of effort and saves time and resources for both companies and regulatory agencies.

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    Impact of CTD

    The CTD fosters a more efficient and collaborative approach to drug development and approval, enabling the simultaneous submission, approval, and launch of new medicines in different countries.

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    Common Technical Document (CTD)

    A standardized format for organizing drug regulatory submissions, encompassing modules 2-5.

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    Module 1

    The first module of a drug regulatory submission, containing jurisdiction-specific administrative information.

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    Module 2

    The second module of a CTD, including summaries of the drug's overall characteristics.

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    Module 3 (Quality)

    The third module of a CTD, focusing on the drug's quality aspects.

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    Module 4 (Non-Clinical)

    The fourth module of a CTD, presenting non-clinical studies on the drug.

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    Module 5 (Clinical)

    The fifth module of a CTD, showcasing clinical trial data and results.

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    Summary Document

    A concise document highlighting key findings and conclusions from the CTD modules.

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    Overview Document

    A comprehensive document providing detailed descriptions and analysis of the data presented in CTD modules.

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    Active Substance Master File (ASMF)

    A comprehensive file that contains all information regarding an active substance, including details about its manufacturing, quality control, and stability. It serves as a vital document for regulatory authorities assessing the safety, efficacy, and quality of a drug.

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    Applicant's "Open" Part of ASMF

    The "open" part of the ASMF that is shared by the applicant for a marketing authorization with regulatory authorities. It contains details about the drug's intended use, formulation, and quality specifications.

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    Active Substance Manufacturer's Restricted "Closed" Part of ASMF

    The "closed" part of the ASMF that is held by the manufacturer of the active substance and shared with regulatory authorities in a restricted format. It includes sensitive information related to the manufacturing process and quality control measures.

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    Governmental Regulatory Control

    A government agency responsible for overseeing the quality, safety, and efficacy of pharmaceuticals and related products within a specific country or region. They set standards, review applications, and issue marketing authorizations for drugs.

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    National Food Safety Authority (NFSA)

    A specific system for regulating natural health products such as dietary supplements. It ensures that these products meet safety, efficacy, and quality standards before they are introduced to the market.

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    Drug Registration in Egypt

    The process of obtaining approval from the Ministry of Health for the sale of any pharmaceutical product in Egypt, applicable to both locally manufactured and imported medicines.

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    Drug Re-registration in Egypt

    A process where drug manufacturers must re-apply for registration every 10 years. Failure to do so results in the cancellation of the permit, preventing further production or import.

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    Fast Track Submission

    A type of drug registration submission with a faster timeline than the standard process.

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    Normal Track Submission

    A standard drug registration submission process.

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    Imported Drug Registration

    The registration process for imported pharmaceuticals is simpler compared to those manufactured locally in Egypt.

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    Toll Pharmaceutical Manufacturer

    A pharmaceutical company operating under a contract with another manufacturing site, responsible for distributing the products of the contracted manufacturer.

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    Agent or Distributor

    A company focused on distributing pharmaceutical products manufactured by other firms.

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    Scientific Office

    A company that handles marketing and advertising for medical products.

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    Study Notes

    Pharmaceutical Technology/Industrial Pharmacy 1 - Lec. 7

    • Product Development Framework: Bringing a new drug to market is complex and controversial, often taking at least ten years. Capital costs are significant, ranging from $500 million to $2 billion. High attrition rates are associated with pharmaceutical development.

    • Success Rates: Well-designed clinical trials, dose-finding studies, and comparisons against a placebo and standard treatment are crucial in reducing attrition rates.

    • Novel Initiatives to Boost Drug Development: Partnering between governmental organizations and industry, such as the Innovative Medicines Initiative (IMI), aims to improve the competitiveness of European Union pharmaceutical research.

    • What Needs to Be Registered?: Medicinal products, veterinary products, medical devices, and cosmetics require registration. Specific drug products have to be classified as innovator or generics.

    • Drug Products: Most commonly, these are small organic molecules affecting biomolecules like proteins. They're used to diagnose, treat, or prevent diseases or disorders.

    • Biological Products: These products are derived from living sources, such as modified living organisms or extracted tissues. Biosimilars are similar but not identical biological products.

    • ICH (International Conference on Harmonization): A global initiative to harmonize technical requirements for registering pharmaceuticals. The ICH aims to achieve harmonization of the interpretation and application of technical guidelines and standards.

    • Egypt's Drug Registration: Central Departments of the Egyptian Drug Authority (EDA) handle drug registration. The process involves several steps before a product can be sold including a pilot batch manufacturing test of 10% of the batch of drug. This stage ensures quality, safety, and efficacy. The relevant process includes drug testing on animals and in humans.

    • Laws (Regulations): Article 59 of Law 127/1955 requires registering pharmaceutical products with the Ministry of Health. Ministerial Decree 174/1974 mandates re-registration every 10 years. Ministerial Decree 450/2023 outlines modern registration procedures.

    • Who Applies for Drug Registration?: Different entities apply for registration depending on the product's nature: factories, toll pharmaceutical manufacturers, manufacturers themselves, agents or distributors, and scientific offices.

    • CTD (Common Technical Document) Structure: A five-module structure for submitting drug registration information used in the European Union and other jurisdictions. Each section contains relevant specific information. The format is intended to be common across different jurisdictions.

    • Brief Summary of Drug Registration Procedures: Steps include box inquiry, naming and pricing, pharmaco-vigilance reports, pilot batch manufacturing, stability and bioequivalence testing, GMP (Good Manufacturing Practices) file documentation, and preparation of patient information leaflets.

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    Pharmaceutical Technology 1/Industrial Pharmacy 1 PDF

    Description

    Explore the complexities of bringing new drugs to market in this lecture. Understand the factors that influence product development, including capital costs and success rates in clinical trials. Learn about the importance of regulatory registration for various drug products.

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