BIOAVAILABILITAS DAN BIOEKIVALENSI

ISTILAH :
Bioavailabilitas ( Ketersediaan hayati ):
Kecepatan (rate) dan Banyak (extent) obat diabsorpsi dari produk obat menjadi tersedia pada tempat aksinya.
Bioekuivalensi :
Perbandingan bioavailabilitas formulasi dan produk obat yang berbeda atau batch yang berbeda untuk produk obat yang sama

ISTILAH
Bioequivalence requirement. A requirement imposed by FDA for in vitro and/or in vivo testing of specified drug products, which must be satisfied as condition for marketing.
Bioequivalence drug products. This term describes pharmaceutical equivalent or pharmaceutical that display comparable bioavailability when studied under similar experimental conditions.
Pharmaceutical alternatives. Drug products that contain the same therapeutic moiety but as different salts, esters, or complexes.
Pharmaceutical equivalents. Drug products in identical dosage forms that contain the same active ingredients), are the same dosage form, use the same route administration, are identical in strength or concentration.
Pharmaceutical substitution. The process of dispensing a pharmaceutical alternative for prescribed drug product.

ISTILAH
Therapeutic alternative. Drugs products containing different active ingredients that are indicated for the same therapeutic or clinical objectives.
Therapeutic equivalent. Drugs products are considered to be therapeutic equivalent only if they are pharmaceutical equivalent and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
Therapeutic substitution. The process of dispensing a therapeutic alternative in place of the prescribed drug product.

Prinsip Dasar Penelitian Bioavailability

Menentukan rancangan percobaan
Seleksi subyek penelitian
Pemilihan sampel
Penentuan metode analisis kadar
Penentuan dosis pemberian
Penentuan banyaknya dan lama pengambilan sampel
Analisis hasil dan evaluasi