Pharmacological Evaluation of Generic Drug

General pharmacology refers to a broad range of pharmacologic studies beyond the primary pharmacodynamic effects, including safety pharmacology and secondary pharmacodynamic studies. Safety pharmacology focuses on the study of potentially undesired adverse effects on physiologic function at doses within or above the therapeutic range of the drug. Additional and/or supplemental safety pharmacology studies may be performed as needed. Pharmacological evaluation of generic drugs is key to the safety evaluation of generic drugs to ensure that they match the reference drug in terms of dose, safety, strength, route of administration, quality, performance characteristics, and intended use. Alfa Chemistry provides professional pharmacological evaluation services to evaluate the efficacy of generic drugs in vitro and in animal models of relevant diseases in accordance with FDA guidelines. Pharmacological studies can be performed to non-GLP or GLP standards.

Alfa Chemistry's Services

Alfa Chemistry has developed a variety of animal models for pharmacological evaluation of generic drug. Each model is designed to understand various aspects of drug characterization and its mechanism of action. By examining our full range of capabilities, clients can develop cost-effective plans that reduce turnaround time and accelerate the generic drug submission process. Our services include:

Safety Pharmacological Evaluation of Generic Drugs

• Central nervous system: Qualitative and quantitative evaluation of motor function, behavioral changes, coordination, sensory/motor reflexes and body temperature, etc.
• Cardiovascular system: Determine the changes in blood pressure (including systolic, diastolic and mean blood pressure), ECG (including QT interval, PR interval, ST segment and QRS wave, etc.), and heart rate before and after drug administration.
• Respiratory system: Determine the changes in respiratory rate and depth of respiration before and after drug administration.

Additional and/or Supplemental Safety Pharmacological Evaluation of Generic Drugs

When safety pharmacological evaluation, clinical trials, epidemiology, ex vivo and in vivo experiments, and reports in the literature suggest that the generic drug has potential to be used in combination with other drugs. We may conduct additional and/or supplemental generic safety pharmacological studies.

Additional Safety Pharmacological Studies:

• Central nervous system: Behavioral, learning and memory, neurobiochemical, visual, auditory, and/or electrophysiological tests.
• Cardiovascular system: Testing of cardiac output, myocardial contractility, vascular resistance, and other indicators.
• Respiratory system: Testing of indicators such as airway resistance, pulmonary artery pressure, and blood gas analysis.

Supplementary Safety Pharmacological Studies:

• Urinary/renal system: Observe the effect of generic drugs on renal function, such as the detection of indicators of urine volume, specific gravity, osmolality, pH, electrolyte balance, proteins, cells, and blood biochemistry (e.g., urea nitrogen, creatinine, protein).
• Autonomic nervous system: Observe the effects of generic drugs on the autonomic nervous system, such as with the autonomic nervous system binding of relevant receptors, functional response to agonists or antagonists in vivo or in vitro, direct stimulatory effect on autonomic nerves and detection of cardiovascular response, pressure reflex and heart rate.
• Gastrointestinal system: Observe the effects of generic drugs on the gastrointestinal system, such as gastric juice secretion and pH, gastrointestinal injury, bile secretion, in vivo transit time, in vitro ileus contraction and other indicators of the test.

Acceptable Biological Samples

• Whole animals: mice, rats, guinea pigs, rabbits, dogs, etc. are commonly used.
• Isolated organs and tissues
• Cells cultured in vitro
• Cell fragments
• Organelles
• Receptors
• Ion channels
• Enzymes, etc.

Our Advantages

• Ensure that the generic drug is as safe and effective as the originator
• Ensure that all pharmacologic evaluations meet regulatory guidelines
• A rigorous evaluation process can help streamline regulatory submissions and help speed up the approval time for generic drugs
• Help reduce the overall cost of bringing a generic drug to market