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DAFTAR ISI

Halaman
DAFTAR ISI.......................................................................................................

BAB I

TINJAUAN FARMAKOLOGI.......................................................... 1

1.1

Golongan Obat Berdasarkan Farmakoterapi......................................... 1

1.2

Indikasi ................................................................................................ 1

1.3

Mekanisme Kerja Obat......................................................................... 1

1.4

Farmakokinetik..................................................................................... 1

1.5

Dosis dan Cara Pemberian.................................................................... 2

1.6

Kontraindikasi....................................................................................... 3

1.7

Efek Samping dan Toksisitas................................................................ 3

1.8

Interaksi Obat........................................................................................ 3

BAB II

PENGUJIAN MUTU SERTA METODE ANALISIS...................... 5

2.1

Tinjauan Umum Zat Aktif dan Aspek Kimia........................................ 5

2.2

Analisis Bahan Baku............................................................................. 6


2.2.1 Analisis Zat Aktif......................................................................... 6
2.2.1 Analisis Bahan Tambahan............................................................ 7

2.3

Validasi Metode Analisis Bahan Baku dan Sediaan............................. 10

2.4

Metode Analisis Sediaan....................................................................... 11

BAB III PENGEMBANGAN FORMULA...................................................... 13


3.1

Contoh Sediaan yang Beredar di Pasaran............................................. 13

3.2

Pra Formulasi dan Alasan Pemilihan Eksipien..................................... 13

3.3

Formulasi, Metode dan Pemilihan Bentuk Sediaan.............................. 18

3.4

Pengujian Stabilitas............................................................................... 20

3.5

Up-Scaling............................................................................................ 25
1

BAB IV MANUFACTURE DAN QC.............................................................. 27


4.1

Aspek-aspek CPOB yang Terkait Proses Produksi............................... 27

4.2

Desain IPC............................................................................................ 31

4.3

Pemilihan Mesin Produksi.................................................................... 36

4.4

Validasi Proses Produksi....................................................................... 37

4.5

Pengemasan.......................................................................................... 38

4.6

Penyimpanan......................................................................................... 39

BAB V

REGULASI DAN PERUNDANGAN................................................ 40

5.1

Registrasi.............................................................................................. 40

5.2

Penandaan Sesuai Undang-Undang...................................................... 41

BAB VI INFORMASI OBAT JADI................................................................. 43


6.1

Pelayanan Informasi Obat..................................................................... 43

6.2

Brosur Obat........................................................................................... 44

DAFTAR PUSTAKA........................................................................................... 45