LAB TOPIC 1

• Stages of drug development:

  1. Preliminary studies
  2. Preclinical studies & Clinical trials
  3. Approval by the regulatory board
  4. Post-marketing surveillance stage
• Preliminary studies involve the synthesis of a new drug compound to determine its potential safety and efficacy
• Approaches to drug discovery:

  • Identification of new potential drug targets, such as proteins like enzymes, ion channels, and receptors
  • Chemical modification of known drug molecules to enhance specificity, increase potency, improve absorption, and reduce toxicity
  • Design and synthesis of new drugs based on understanding biological mechanisms and drug structures
  • Combinations of known drugs to obtain additive or synergistic effects
  • Screening natural products, chemical entities, and organic molecules for biologic activity
• Biotechnology and gene cloning aim to produce peptides and proteins, such as using stem cells for treatment
• Preclinical studies involve laboratory animal testing to determine drug efficacy and safety, including acute and chronic toxicity tests
• Clinical trials aim to determine drug safety and efficacy on target species, noting toxic/adverse effects, tissue residue levels, and withdrawal time
• Clinical trials have different phases:

  • Phase 1: Dose-finding with acute and chronic toxicity tests
  • Phase 2: Efficacy testing in an increased number of test animals with the disease
  • Phase 3: Comparative study to determine drug efficacy and adverse reactions by comparing with existing treatments
• If tests are favorable, a new drug is approved for marketing, common reasons for non-approval include side effects, less effectiveness, and lack of financial viability
• Involves monitoring the product after it is marketed to ensure safety, efficacy, and detect adverse drug reactions through pharmacovigilance activities
• Reporting side effects can be done online or through manual submission
• Minimum requirements for evaluating the efficacy and safety of veterinary drugs to test animals:
• Local regulatory agencies involved in animal health products include the Food and Drug Administration (FDA) for registration and licensing/monitoring of veterinary products, and the Bureau of Animal Industry (BAI) for regulating veterinary establishments
• Requirements for drugs with a satisfactory history of use in developed countries:
• Target animal safety studies involve toxicity tests to determine the margin of safety, including monitoring clinical signs, hematological parameters, and serum biochemical tests
• Reproductive studies aim to determine the drug's effect on breeding and embryo/fetus development by administering doses at specific times during pregnancy
• Target animal efficacy studies involve conducting trials in animals diagnosed with the disease to demonstrate the effects claimed on the drug label through quantitative and qualitative measurements