Table 2.
Reproductive and developmental toxicity with telbivudine
| Study type | Route of administration | Species | No. of animals | Doses (mg/kg per day) | Treatment | Reference |
| Rat studies | ||||||
| Fertility, reproduction, | Oral gavage | Sprague Dawley rats | 25 males | 0, 100, 500, 1000 | Males: -28 AC to DG 17 | Study 1314-001 |
| developmental | 25 females | Females: -15 AC to DG 17 | ||||
| Fertility | Oral gavage | Sprague Dawley rats | 25 males | 0, 1000, 2000 | Males: -28 AC to DG 13 | Study 1314-005 |
| 25 females | ||||||
| Fertility | Oral gavage | Sprague Dawley rats | 25 males | 0, 2000 | Females: -15 AC to DG 7 | Study 1314-006 |
| 25 females | ||||||
| Peri/postnatal | Oral gavage | Sprague Dawley rats | 25 females | 0, 100, 250, 1000 | Females: DG 7 to DL 20 | Study 1314-003 |
| Rabbit study | ||||||
| Developmental | Oral gavage | New Zealand White rabbits | 20 females | 0, 50, 250, 1000 | Females: DG 6-18 | Study 1314-002 |
AC: Ante coitum; DG: Gestation day; DL: Lactation day.