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  1. Introduction to BiopharmaceuticalsUG Course Touqeer Ahmed Ph.D. Atta-ur-Rahman School of Applied Bioscience National University of Sciences and Technology 9th September, 2014

  2. Course Contents • Kinetics of Biopharmaceuticals • One Compartment Open Model ' IV Bolus Injection • Multicompartmental Models ' IV Bolus Injection • Drug Elimination and Clearance • Pharmacokinetics of Oral Absorption • Multiple Dosage Regimens • Nonlinear Pharmacokinetics • Physiologic Drug Distribution and Protein Binding • Renal and Hepatic Elimination of Drugs • Bioavailability and Bioequivalence • Immunogenicity of Biopharmaceuticals • Regulatory Compliance for Biopharmaceuticals and Biologics • Application of Pharmacokinetics in Clinical Situations Biopharmaceuticals • Introduction to the Biopharmaceuticals/drugs • Pharmacokinetic and Pharmacodynamics • Introduction to biopharmaceuticals and their Pharmacokinetics • Active Pharmaceutical Ingredient (API) and Drug Product Specifications • Biopharmaceutical Products: • Antibodies • Monolconal • Polyclonal • Bi-specific • Hormones • Enzymes • Interferon • Thrombolytic agents (tissue plasminogen activator) • Drug Development and its phases

  3. Recommended Books

  4. Evaluation System • Assignments 10 • Quiz 20 • First Sessional 10 • Second Sessional 10 • Final Exams (Terminal Exams) 50

  5. Introduction to Biopharmaceuticals/Drugs • Touqeer Ahmed Ph.D. • Atta-ur-Rahman School of Applied Bioscience, • National University of Sciences and Technology, • Islamabad • 17th September, 2014

  6. Drugs In the most general sense, a drug may be defined as any substance that brings about a change in biological function through its chemical actions. • Drugs may be • Hormones synthesized in the body • Xenobiotics not synthesized in the body • Poisons drugs having exclusively harmful effect (e.g. lead and arsenic) • Toxins are usually defined as poisons of biologic origin syntehsized by the plants and animals) 1. PHYSICAL NATURE • solid at room temperature (eg, aspirin, atropine), • liquid (eg, nicotine, ethanol) • gas (eg, nitrous oxide). 2. DRUG SIZE ((lithium ion, MW 7) to very large (eg, alteplase [t-PA], a protein of MW 59,050) 3. DRUG SHAPE (Chirality (stereoisomerism) 4. DRUG REACTIVITY AND DRUG-RECEPTOR BONDS Covalent, electrostatic and hydrophobic

  7. Drug and Medicine • What is a drug? • A drug can be defined as a chemical substance of known (and sometimes unknown structure), other than a nutrient or an essential dietary ingredient,which, when administered to a living organism, produces a biological effect. • To count as a drug, the substance must be administered, rather than released by physiological mechanisms. Many substances, such as insulin or thyroxine, are endogenous hormones but are also drugs when they are administered intentionally. • What is a medicine? • A medicine is a chemical preparation, which usually but not necessarily contains one or more drugs, administered with the intention of producing a therapeutic (healing/recovery from disease) effect. • Medicines usually contain other substances (excipients, stabilisers, solvents, etc.) besides the active drug, to make them more convenient to use.

  8. Biopharmaceuticals • Biopharmaceuticals are the drugs which are produced using biotechnology. They include proteins (including antibodies), nucleic acids and living microorganisms like virus and bacteria where their virulence is reduced by the process of attenuation.

  9. BiopharmaceuticalsBiopharmaceutics • The study of the chemical and physical properties of drugs, their components, and their activities in living organisms. Biopharmaceutics Drug release and dissolutions Drug in systemic circulation Drug in tissues Pharmacological effect Excretion and metabolism

  10. Pharmacokinetics and Pharmacodynamics • Pharmacokinetics deals with the study of kinetics of drug absorption, distribution and elimination • Elimination: is composed of collective processes of excretion and metabolism • Drug disposition: collectively drug distribution and elimination Clinical pharmacokinetics Study of the drug kinetics based on the clinical observations such as the patients disease state and patient specific consideration (e.g. age, sex and ethnicity) Pharmacodynamics Deals with the study of drug concentration at the site of action and the pharmacologic response produced by the drug.

  11. Drug Targets • Protein targets for drug binding Four main kinds of regulatory protein are commonly involved as primary drug targets, namely: 1.receptors (activate signaling pathways) 3.enzymes 2. carrier molecules (transporters) 4.ion channels. • Agonists and antagonists Agonists, which 'activate' the receptors, and antagonists, which combine at the same site • and block the effect of agonists • by inhibiting the activation of • receptors.