Biopharmaceutics. Группа авторов

      List of Illustrations

      1 Chapter 1Figure 1.1 Schematic of the fate of drugs once administered orally; biopharm...Figure 1.2 Frequency of biopharmaceutics as a MESH terms in publications ver...Figure 1.3 Overview of the biopharmaceutics timeline of key events.Figure 1.4 Overview of biopharmaceutics input in the drug development pathwa...

      2 Chapter 2Figure 2.1 Illustration showing a typical life cycle of a drug in the body (...Figure 2.2 A typical pharmacokinetic profile (plasma drug concentration–time...Figure 2.3 A typical pharmacokinetic profile (plasma concentration–time prof...Figure 2.4 Physicochemical and physiological factors affecting the absorptio...Figure 2.5 Illustration explaining how plasma and serum differ from blood.Figure 2.6 A typical drug distribution into the body following an intravenou...Figure 2.7 An illustration of the renal tubule (nephron) and its cortex and ...Figure 2.8 Plasma drug concentration–time profile followed by an intravenous...Figure 2.9 The relationship of total body clearance, renal and non‐renal cle...Figure 2.10 An illustration showing the calculation of AUC in a plasma drug ...Figure 2.11 Repeat dose pharmacokinetic profile showing steady state compare...Figure 2.12 One‐compartmental pharmacokinetic model, distribution equilibriu...Figure 2.13 Two‐compartmental pharmacokinetic model, distribution equilibriu...Figure 2.14 The linear relationship of the administered dose with the area‐u...Figure 2.15 Illustration showing non‐linear increase in steady state concent...

      3 Chapter 3Figure 3.1 Image of transport pathways across a cellular membrane.Figure 3.2 Schematic diagram to demonstrate the impact of ionisation on the ...Figure 3.3 Impact of log D vs pH for a compound with a pKa value of 4.5....

      4 Chapter 4Figure 4.1 Image showing plasma pharmacokinetics from a study in which an or...Figure 4.2 Impact of pH on solubility of a weakly acidic and a weakly basic ...Figure 4.3 Comparison of the solubility of a series of drugs in blank FaSSIF...Figure 4.4 Examples of solubility vs time plots for a rapidly dissolving sol...

      5 Chapter 5Figure 5.1 How compounds cross the intestinal epithelial barrier and key fea...Figure 5.2 Cartoon to show loss of drug at the gut wall and the liver due to...Figure 5.3 Cartoon showing efflux of a drug due to an ABC transporter.Figure 5.4 A cartoon to show the combined impact of P‐g and CYP3A4 on the po...Figure 5.5 Cellular location of intestinal transporters involved in oral dru...Figure 5.6 Examples of tools used to predict intestinal permeability.Figure 5.7 Correlation between human jejunal and PAMPA permeabilities.Figure 5.8 Schematic of drug transport assay in Caco‐2 cell monolayers cultu...Figure 5.9 Schematic of a small piece of intestinal epithelial tissue mounte...Figure 5.10 Schematic of ex vivo everted intestinal sac experiment. (a) Inte...Figure 5.11 Schematic drawing of in situ intestinal perfusion with venous sa...Figure 5.12 Schematic drawing of the Loc‐I‐Gut instrument.

      6 Chapter 6Figure 6.1 Cartoon of USP dissolution apparatus; type 1 on the left with a b...Figure 6.2 Cartoon of USP3 dissolution apparatus. On the left is the recipro...Figure 6.3 Cartoon of USP4 apparatus. This can be run in an open system or a...Figure 6.4 A schematic overview of a level A IVIVC.

      7 Chapter 7Figure 7.1 Biopharmaceutics considerations in drug discovery (HI, hit identi...Figure 7.2 Schematic of biopharmaceutics activity demonstrating that deeper ...Figure 7.3 Simple overview of how molecular or product design can provide th...Figure 7.4 Example BCS visualisation for an early discovery project. Human P...Figure 7.5 Predictions of the human fraction absorbed (in the fasted state) ...Figure 7.6 Rational formulation selection decision tree for early developmen...

      8 Chapter 8Figure 8.1 Overview of the formulation strategies and associated biopharmace...Figure 8.2 Formulation selection strategies based on BCS. DV, dose to volume...Figure 8.3 An overview of the Developability Classification System (DCS)....Figure 8.4 Formulation selection strategies based on refined DCS. SFaHIF , d...Figure 8.5 Simulated human PK profiles for three controlled‐release (CR) for...Figure 8.6 QTPP guiding formulation strategy based on appropriate justificat...Figure 8.7 Factors considered in the QTPP of a formulation to be administere...Figure 8.8 The Biopharmaceutics Risk Assessment Roadmap (BioRAM). Boxes 1–6 ...Figure 8.9 Therapy‐driven formulation strategy based on the Biopharmaceutics...

      9 Chapter 9Figure 9.1 Classification of drugs into four BCS groups based on their solub...Figure 9.2 BCS Classification of WHO Essential drugs using metoprolol as the...

      10 Chapter 10Figure 10.1 Schematic of ‘standard’ clinical bioequivalence study design....Figure 10.2 Forest plot representing potential outcomes of the T/R results f...Figure 10.3 Four drug delivery scenarios depicted as drug‐concentration time...Figure 10.4 Submission structure and Common Technical Document Module Conten...

      11 Chapter 11Figure 11.1 Stomach anatomy.Figure 11.2 Schematic representation of (a) peristaltic contractions waves i...Figure 11.3 Diagram of the small intestine with the duodenum, jejunum and il...Figure 11.4 Literature data on reported small intestinal fluid volumes in a ...Figure 11.5 Diagram of the large intestine.

      12 Chapter 12Figure 12.1 Structure of the compartmentalised gut model into the whole body...Figure 12.2 Schematic representation of the phenomena which takes place in t...Figure 12.3 Schematic representation of a dissolving drug particle and conce...Figure 12.4 Log PMW of five drugs at various mobile phase pH values.Figure 12.5 Sequential workflow for integrating in vitro solubility and diss...

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