WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report (1996; 200 pages)  Table des matières
Appendix 1 - Examples of national requirements for in vivo equivalence studies for drugs included in the WHO Model List of Essential Drugs (Canada, Germany and the USA, December 1994)
General
National requirements for equivalence studies for specific drug products differ from country to country. National requirements for equivalence studies of a specific drug product can be based on any of the following:
- case-by-case study;
- criteria established by a national advisory committee; or
- application of the national regulatory guidelines.
A list of examples is presented in Table 1. It is intended to be illustrative only, in accordance with the guidelines, and does not represent a formal recommendation.
The list is based on substances and products included in the WHO Model List of Essential Drugs (1), but only includes essential drugs for which in vivo studies are required because of the nature of the dosage form. Some dosage forms, e.g. solutions and injections, have therefore been omitted from the list as they have not been identified as requiring studies in one of the three countries covered.
Examples of decisions on criteria taken by national authorities
Canada
At present, demonstration of bioequivalence is required for those drugs which are not considered to have been marketed in Canada for their intended purpose(s) for sufficient time and in sufficient quantity to establish safety and efficacy (new drugs). Bioequivalence may be demonstrated by comparative bioequivalence studies or by clinical studies including, where applicable, acceptable surrogate models. Scientific criteria, similar to those of the European Community and Australia, are being developed for deciding in which situations in vivo demonstration of bioequivalence is required for drugs that are not new.
Germany
Over the past years, the National Advisory Committee has taken the decision on the need for a comparative bioavailability/bioequivalence study as a requirement for marketing authorization. These decisions have been based on published data for the drug substance and its dosage form, and on the use of an algorithm. Details of the algorithm, the criteria and the resulting decisions have been published in the German Federal Register. In certain circumstances, the regulatory authority takes decisions on a case-by-case basis.
USA
Drug products introduced before 1938 in the USA do not require approval for marketing and therefore no in vivo equivalence study is needed. The majority of drug products, other than solution dosage forms, approved between 1938 and 1962, and known to have potential bioavailability problems, require in vivo equivalence studies. Generally, drug products approved after 1962, with the exception of solution dosage forms, also require in vivo equivalence studies.
Table 1
Examples of national requirements for equivalence studies1
Drug substance |
Dosage form |
Canada |
Germany |
USA |
acetazolamide |
tablet, 250 mg |
+b |
+b |
+b |
acetylsalicylic acid |
suppository, 50-150 mg |
? |
+b |
- |
| |
tablet, 100-500 mg |
- |
+b |
- |
albendazole |
tablet, 200 mg |
o |
+b |
o |
allopurinol |
tablet, 100 mg |
+b |
+b |
+b |
aluminium hydroxide |
oral suspension, 320 mg/5 ml |
- |
+p |
- |
| |
tablet, 500 mg |
- |
+p |
- |
amiloride hydrochloride |
tablet, 5 mg |
+b |
- |
+b |
aminobenzoic acid |
cream |
? |
+p+c |
|
| |
gel |
? |
+p+c |
- |
| |
lotion |
? |
+p+c |
- |
aminophylline |
tablet, 100 mg, 200 mg |
? |
o |
+b |
amitriptyline hydrochloride |
tablet, 25 mg |
? |
+b |
+b |
amoxicillin |
capsule, 250 mg, 500 mg |
+b |
+b |
+b |
| |
powder for oral suspension, 125 mg/5 ml |
+b |
+b |
+b |
| |
tablet, 250 mg, 500 mg |
+b |
+b |
+b |
ascorbic acid |
tablet, 50 mg |
- |
? |
- |
atenolol |
tablet, 50 mg, 100 mg |
+b |
- |
+b |
atropine sulfate |
solution (eye drops), 0.1%, 0.5%, 1% |
o |
+c |
- |
| |
tablet, 1 mg |
o |
? |
o |
azathioprine |
tablet, 50 mg |
+b |
+b |
+b |
bacitracin zinc |
ointment, 500 IU + neomycin sulfate, 5 mg/g |
o |
+c |
- |
beclometasone dipropionate |
inhalation. 50 µg/dose |
? |
+p+c |
+p |
benzathine benzylpenicillin |
powder for injection, 1.44 g of benzylpenicillin (= 2.4 million IU) in 5-ml vials |
o |
- |
+b |
benznidazole |
tablet, 100 mg |
o |
+b |
o |
benzoic acid |
cream, 6% + salicylic acid, 3% |
- |
+p+c |
o |
| |
ointment, 6% + salicylic acid. 3% |
- |
+p+c |
- |
benzoyl peroxide |
cream, 5% |
- |
+p+c |
- |
| |
lotion, 5% |
- |
+p+c |
- |
benzyl benzoate |
lotion, 25% |
- |
+p+c |
o |
betamethasone valerate |
cream, 0.1% of betamethasone |
+p |
+p+c |
+p |
| |
ointment, 0.1% of betamethasone |
+p |
+p+c |
+p |
biperiden hydrochloride |
tablet, 2 mg |
+b |
+b |
+b |
calamine |
lotion |
|
+p+c |
|
calcium folinate |
tablet, 15 mg |
+b |
o |
+b |
captopril |
tablet, 25 mg |
+b |
- |
+b |
carbamazepine |
tablet, 100 mg, 200 mg |
+b |
+b |
+b |
carbidopa |
tablet, 10 mg + levodopa, 100 mg |
+b |
+b |
+b |
| |
25 mg + levodopa, 250 mg |
+b |
+b |
+b |
chloramphenicol |
capsule, 250 mg |
? |
+b |
+b |
chloramphenicol palmitate |
oral suspension. 150 mg of chloramphenicol/5 ml |
? |
+b |
+b |
chloramphenicol sodium succinate |
oily suspension, injection 0.5 g of chloramphenicol/ml in 2-ml ampoule |
o |
+b |
o |
chloroquine hydrochloride |
injection, 40 mg of chloroquine/ml in 5-ml ampoule |
o |
- |
- |
chloroquine phosphate |
tablet. 150 mg of chloroquine |
o |
+b |
- |
chloroquine sulfate |
tablet. 150 mg of chloroquine |
c |
+b |
o |
chlorphenamine hydrogen maleate |
tablet, 4 mg |
- |
? |
- |
chlorpromazine hydrochloride |
tablet, 100 mg |
? |
+b |
+b |
ciclosporin |
capsule, 25 mg |
+b |
+b |
+b |
cimetidine |
tablet, 200 mg |
+b |
- |
+b |
ciprofloxacin hydrochloride |
tablet, 250 mg of ciprofloxacin |
+b |
+b |
+b |
clofazimine |
capsule, 50 mg, 100 mg |
o |
+b |
+b |
clomifene citrate |
tablet, 50 mg |
+b |
+b |
+b |
clomipramine hydrochloride |
capsule, 10 mg, 25 mg |
+b |
o |
+b |
cloxacillin sodium |
capsule, 500 mg of cloxaxillin |
? |
+b |
+b |
codeine phosphate |
tablet, 10 mg, 30 mg |
o |
- |
- |
colchicine |
tablet, 500 µg |
? |
+b |
- |
cyclophosphamide |
tablet, 25 mg |
+b |
+b |
+b |
dapsone |
tablet, 50 mg, 100 mg |
? |
+b |
+b |
desmopressin acetate |
nasal spray, 10 µg/metered dose |
+b+p |
+p+c |
? |
dexamethasone |
tablet, 500 µg, 4 mg |
? |
? |
+b |
diazepam |
scored tablet, 2 mg, 5 mg |
+b |
- |
+b |
diethylcarbamazine dihydrogen citrate |
tablet, 50 mg |
o |
+b |
+b |
digitoxin |
tablet, 50 µg, 100 µg |
? |
+b |
- |
digoxin |
tablet, 62.5 µg, 250 µg |
? |
+b |
- |
diloxanide furoate |
tablet, 500 mg |
o |
+b |
o |
dimercaprol |
injection, in oil 50, mg/ml in 2-ml ampoule |
+b+c |
+b2 |
- |
dioxybenzone |
cream |
? |
+p+c |
o |
| |
lotion |
? |
+p+c |
o |
| |
gel |
? |
+p+c |
o |
dithranol |
ointment, 0.1-2% |
- |
+p+c |
- |
doxycycline hyclate |
capsule, 100 mg of doxycycline |
+b |
+b |
+b |
| |
tablet, 100 mg of doxycycline |
+b |
+b |
+b |
ergocalciferol |
capsule, 1.25 mg (50 000 IU) |
o |
+b |
|
| |
tablet, 1.25 mg (50 000 IU) |
o |
+b |
- |
ergometrine hydrogen maleate |
tablet, 200 µg |
? |
+b |
- |
ergotamine tartrate |
tablet, 2 mg |
o |
+b |
- |
erythromycin |
capsule, 250 mg of erythromycin |
? |
+b |
+b |
ethylsuccinate |
powder for oral suspension, 125 mg of erythromycin |
? |
+b |
+b |
| |
tablet, 250 mg of erythromycin |
? |
+b |
+b |
erythromycin stearate |
capsule, 250 mg of erythromycin |
? |
+b |
+b |
| |
powder for oral suspension, 125 mg of erythromycin |
? |
+b |
+b |
| |
tablet, 250 mg of erythromycin |
? |
+b |
+b |
ethambutol hydrochloride |
tablet, 100-400 mg |
+b |
+b |
+b |
ethinylestradiol |
tablet, 50 µg |
+b |
+b |
+b |
| |
tablet, 30 µg + levonorgestrel 150 µg |
+b |
+b |
+b |
| |
50 µg + levonorgestrel, 250 µg |
+b |
+b |
+b |
| |
tablet, 35 µg + norethisterone, 1.0 mg |
+b |
+b |
+b |
ethosuximide |
capsule, 250 mg |
? |
+b |
+b |
etoposide |
capsule, 100 mg |
+b |
+b |
+b |
ferrous sulfate |
tablet, 60 mg of Fe |
|
o |
|
| |
tablet, 60 mg of Fe + folic acid, 250 µg |
|
o |
- |
flucytosine |
capsule, 250 mg |
+b |
+b |
+b |
fludrocortisone acetate |
tablet, 100 µg |
+b |
+b |
+b |
fluorouracil |
ointment, 5% |
+c |
+p+c |
? |
fluphenazine decanoate |
injection, 25 mg in 1 -ml ampoule |
? |
+b2 |
- |
fluphenazine enantate |
injection, 25 mg in 1 -ml ampoule |
? |
+b2 |
- |
folic acid |
tablet, 5 mg, 1 mg |
+b |
+b |
- |
| |
tablet, 250 µg + ferrous sulfate, 60 mg of Fe |
- |
+b |
- |
furosemide |
tablet, 40 mg |
+b |
+b |
+b |
gentamicin sulfate |
solution (eye drops), 0.3% |
+c |
+p+c |
- |
glyceryl trinitrate |
tablet (sublingual), 500 µg |
? |
+b |
- |
griseofulvin |
capsule, 125 mg, 250 mg |
? |
+b |
+b |
| |
tablet, 125 mg, 250 mg |
? |
+b |
+b |
haloperidol |
tablet, 2 mg, 5 mg |
+b |
- |
+b |
hydralazine hydrochloride |
tablet, 25 mg, 50 mg |
o |
+b |
- |
hydrochlorothiazide |
tablet, 25 mg, 50 mg |
? |
- |
+b |
hydrocortisone acetate |
cream, 1% |
o |
+p+c |
- |
| |
ointment, 1% |
o |
+p+c |
- |
| |
suppository, 25 mg |
o |
+p+c |
? |
ibuprofen |
tablet, 200 mg |
+b |
- |
+b |
idoxuridine |
eye ointment, 0.2% |
o |
+p+c |
+c |
| |
solution (eye drops) 0.1% |
o |
- |
- |
indometacin |
capsule, 25 mg |
+b |
- |
+b |
| |
tablet, 25 mg |
+b |
- |
o |
insulin: insulin (soluble) |
injection, 40 IU/ml in 10-ml vial, |
+b |
- |
+b+p |
| |
80 IU/ml in 10-ml vial, |
+b |
- |
+b+p |
| |
100 IU/ml in 10-ml vial |
+b |
- |
+b+p |
insulin zinc suspension |
injection, 40 IU of insulin/ml in 10-ml vial |
+b |
o |
+b+p |
| |
80 IU of insulin/ml in 10-ml vial |
+b |
o |
+b+p |
insulin (intermediate-acting) |
100 IU of insulin/ml in 10-ml vial |
+b |
- |
+b+p |
isophane insulin |
injection, 40 IU of insulin/ml in 10-ml vial |
+b |
+b |
+b+p |
| |
80 IU of insulin/ml in 10-ml vial |
+b |
+b |
+b+p |
| |
100 IU of insulin/ml in 10-ml vial |
+b |
+b |
+b+p |
iodized oil |
capsule, 200 mg |
? |
o |
o |
iopanoic acid |
tablet, 500 mg |
o |
o |
- |
iron dextran |
injection, 50 mg of Fe/ml in 2-ml ampoule |
+c |
- |
+b+p |
isoniazid |
tablet, 100-300 mg |
+b |
+b |
- |
| |
tablet, 100 mg + rifampicin, 150 mg |
o |
+b |
+b |
| |
150 mg + rifampicin, 300 mg |
o |
+b |
+b |
| |
tablet, 100 mg + thioacetazone, 50 mg |
o |
+b |
o |
| |
300 mg + thioacetazone. 150 mg |
o |
+b |
o |
isosorbide dinitrate |
tablet (sublingual), 5 mg |
+b |
+b |
+b |
ivermectin |
scored tablet, 6 mg |
o |
+b |
o |
ketoconazole |
oral suspension, 100 mg/5 ml |
+b |
+b |
+b |
| |
tablet, 200 mg |
+b |
+b |
+b |
levamisole hydrochloride |
tablet, 50 mg, 150 mg |
+b |
+b |
+b |
levodopa |
tablet, 100 mg + carbidopa, 10 mg |
+b |
+b |
+b |
| |
250 mg + carbidopa, 25 mg |
+b |
+b |
+b |
levonorgestrel |
tablet, 150 µg + ethinylestradiol, 30 µg |
+b |
+b |
+b |
| |
250 µg + ethinylestradiol, 50 µg |
+b |
+b |
+b |
levothyroxine sodium |
tablet, 50 µg, 100 µg |
? |
+b |
- |
lithium carbonate |
capsule, 300 mg |
+b |
+b |
+b |
| |
tablet, 300 mg |
+b |
+b |
+b |
mebendazole |
chewable tablet, 100 mg |
+b |
+b |
+b+c |
medroxyprogesterone acetate (depot) |
injection, 150 mg/ml in 1-ml vial, |
? |
+*b |
+b |
| |
50 mg/ml in 3-ml vial |
? |
+*b |
+b |
mefloquine hydrochloride |
tablet, 250 mg |
+b |
+b |
+b |
mercaptopurine |
tablet, 50 mg |
+c+b |
+b |
+b |
methionine (DL-) |
tablet, 250 mg |
? |
? |
- |
methotrexate sodium |
tablet, 2.5 mg of methotrexate |
+b+c |
+b |
+b |
methyldopa |
tablet, 250 mg |
? |
+b |
+b |
metoclopramide hydrochloride |
tablet, 10 mg of metoclopramide |
+b |
- |
+b |
metrifonate |
tablet, 100 mg |
o |
+b |
o |
metronidazole |
suppository, 500 mg, 1 g |
o |
+b |
o |
| |
tablet, 200-500 mg |
+b |
+b |
+b |
metronidazole benzoate |
oral suspension, 200 mg of metronidazole/5 ml |
o |
+b |
o |
mexenone |
cream |
o |
+p+c |
o |
| |
lotion |
o |
+p+c |
o |
| |
gel |
o |
+p+c |
o |
miconazole nitrate |
cream, 2% |
+c |
+p+c |
+c |
| |
ointment, 2% |
+c |
+p+c |
+c |
morphine sulfate |
tablet, 10 mg |
o |
+b |
- |
nalidixic acid |
tablet, 500 mg |
+b |
+b |
+b |
neomycin sulfate |
ointment, 5 mg + bacitracin zinc, 500 IU/g |
o |
+p+c |
- |
neostigmine bromide |
tablet, 15 mg |
? |
? |
- |
niclosamide |
chewable tablet, 500 mg |
o |
+b |
+b |
nicotinamide |
tablet, 50 mg |
- |
? |
- |
nifedipine |
capsule, 10 mg |
+b |
+b |
+b |
| |
tablet, 10 mg |
+b |
+b |
o |
nifurtimox |
tablet, 30 mg, 120 mg, 250 mg |
o |
+b |
o |
nitrofurantoin |
tablet, 100 mg |
? |
+b |
+b |
norethisterone |
tablet, 350 µg, 5 mg |
+b |
+b |
o |
| |
tablet, 1.0 mg + ethinylestradiol, 35 µg |
+b |
+b |
o |
norethisterone enantate |
oily solution, 200 mg/ml in 1-ml ampoule |
? |
+b |
o |
nystatin |
lozenge, 100 000 IU |
+ |
? |
+b |
| |
tablet, 100000 IU, 500000 IU |
o |
- |
- |
oxamniquine |
capsule, 250 mg |
o |
+b |
+b |
oxybenzone |
cream |
- |
+p+c |
+c |
| |
gel |
- |
+p+c |
+c |
| |
lotion |
- |
+p+c |
+c |
paracetamol |
suppository, 100 mg |
+b |
- |
o |
| |
tablet, 100-500 mg |
- |
- |
o |
penicillamine |
capsule, 250 mg |
+b |
- |
+b |
| |
tablet, 250 mg |
+b |
- |
+b |
permethrin |
lotion, 1% |
- |
+p+c |
+c |
pethidine hydrochloride |
tablet, 50 mg, 100 mg |
o |
+b |
- |
phenobarbital |
tablet, 15-100 mg |
- |
o |
- |
phenoxymethyl-penicillin potassium |
powder for oral suspension, 250 mg of phenoxymethyl-penicillin/5 ml |
o |
+b |
+b |
| |
tablet, 250 mg of phenoxymethylpenicillin |
? |
+b |
+b |
phenytoin sodium |
capsule, 25 mg, 100 mg |
+b |
+b |
+b |
| |
tablet, 25 mg, 100 mg |
+b |
+b |
o |
phytomenadione |
tablet, 10 mg |
+b |
o |
+b |
pilocarpine hydrochloride |
solution (eye drops), 2%, 4% |
o |
+p+c |
- |
pilocarpine nitrate |
solution (eye drops), 2%. 4% |
o |
+p+c |
o |
piperazine adipate |
tablet, 500 mg of piperazine hydrate |
- |
o |
o |
piperazine citrate |
tablet, 500 mg of piperazine hydrate |
- |
o |
+b |
podophyllum resin |
solution, topical, 10-25% |
o |
+p+c |
- |
potassium iodide |
tablet, 60 mg |
- |
- |
- |
praziquantel |
tablet, 150 mg, 600 mg |
o |
+b |
+b |
prednisolone |
solution (eye drops), 0.5% |
o |
+p+c |
o |
| |
tablet, 1 mg. 5 mg |
? |
+b |
+b |
primaquine diphosphate |
tablet, 7.5 mg of primaquine. 15 mg of primaquine |
? |
+b |
- |
procainamide hydrochloride |
tablet, 250 mg, 500 mg |
+b |
+b |
+b |
procaine benzylpenicillin |
powder for injection, |
|
|
|
| |
1 g (= 1 million IU), |
? |
- |
+b |
| |
3 g (= 3 million IU) |
o |
- |
+b |
procarbazine hydrochloride |
capsule, 50 mg |
+c+b |
+b |
+b |
proguanil hydrochloride |
tablet, 100 mg |
o |
+b |
o |
promethazine hydrochloride |
tablet, 10 mg, 25 mg |
? |
+b |
+b |
propranolol hydrochloride |
tablet, 10 mg, 20 mg 40 mg, 80 mg |
+b |
+b |
+b |
propyliodone |
oily suspension, 500-600 mg/ml in 20-ml ampoule |
o |
o |
- |
propylthiouracil |
tablet, 50 mg |
? |
- |
+b |
pyrantel embonate |
oral suspension, 50 mg of pyrantel/ml |
o |
+b |
+b |
| |
chewable tablet, 250 mg of pyrantel |
o |
+b |
o |
pyrazinamide |
tablet, 500 mg |
+b |
+b |
+b |
pyridostigmine bromide |
tablet, 60 mg |
+b |
? |
+b |
pyridoxine hydrochloride |
tablet, 25 mg |
- |
? |
- |
pyrimethamine |
tablet, 25 mg + sulfadoxine, 500 mg |
+b |
+b |
+b |
quinidine sulfate |
tablet, 200 mg |
? |
+b |
+b |
quinine bisulfate |
tablet, 300 mg of quinine |
+b |
+b |
- |
quinine sulfate |
tablet, 300 mg of quinine |
? |
+b |
- |
reserpine |
tablet, 100 µg, 250 µg |
? |
+b |
+b |
retinol palmitate |
capsule, 200000 IU (110 mg) of retinol |
- |
? |
o |
| |
sugar-coated tablet, 10000 IU of retinol |
- |
? |
o |
riboflavin |
tablet, 5 mg |
- |
? |
- |
rifampicin |
capsule, 150 mg, 300 mg |
+b |
+b |
+b |
| |
tablet, 150 mg, 300 mg |
+b |
+b |
+b |
| |
tablet, 150 mg + isoniazid, 100 mg |
o |
+b |
+b |
| |
300 mg + isoniazid, 150 mg |
o |
+b |
+b |
salbutamol sulfate |
inhalation (aerosol), 100 µg of salbutamol per dose |
?,+p |
+p+c |
+p |
| |
respirator solution for use in nebulizers, 5 mg/ml |
?,+p |
+p+c |
- |
| |
tablet, 2 mg, 4 mg of salbutamol |
+b |
+b |
+b |
salicylic acid |
cream, 3% + benzoic acid, 6% |
- |
+p+c |
o |
| |
ointment, 3% + benzoic acid, 6% |
- |
+p+c |
- |
| |
solution, topical, 5% |
- |
+p+c |
o |
silver nitrate |
solution (eye drops), 1% |
o |
+p+c |
- |
silver sulfadiazine |
cream, 1% in 500-g container |
+c |
+p+c |
+c |
sodium cromoglicate |
inhalation, 20 mg/dose |
?or+c |
+p+c |
+p+c |
sodium fluoride |
tablet, 500 µg |
- |
- |
- |
sodium valproate |
enteric coated tablet, 200 mg, 500 mg |
+b |
+b |
+b |
spironolactone |
tablet, 25 mg |
+b |
+b |
+b |
sulfadimidine |
tablet, 500 mg |
o |
+b |
o |
sulfadoxine |
tablet, 500 mg + pyrimethamine, 25 mg |
+b |
+b |
+b |
sulfamethoxazole |
oral suspension 200 mg + trimethoprim, 40 mg/5 ml |
+b |
+b |
+b |
| |
tablet, 100 mg + trimethoprim. 20 mg |
+b |
+b |
+b |
| |
400 mg + trimethoprim, 80 mg |
+b |
+b |
+b |
sulfasalazine |
tablet, 500 mg |
+b |
+b |
+b |
tamoxifen citrate |
tablet, 10 mg of tamoxifen, 20 mg of tamoxifen |
+b |
+b |
+b |
testosterone enantate |
injection. 200 mg in 1-ml ampoule |
? |
+b |
- |
tetracaine hydrochloride |
solution (eye drops). 0.5% |
o |
+p+c |
- |
tetracycline |
capsule, 250 mg |
? |
+b |
+b |
hydrochloride |
tablet, 250 mg |
? |
+b |
+b |
| |
eye ointment, 1% |
? |
+p+c |
- |
thiamine hydrochloride |
tablet, 50 mg |
- |
? |
- |
thioacetazone |
tablet, 50 mg + isoniazid, 100 mg |
o |
+b |
o |
| |
150 mg + isoniazid, 300 mg |
o |
+b |
o |
tolbutamide |
tablet, 500 mg |
+b |
+b |
+b |
trimethoprim |
oral suspension, 40 mg + sulfamethoxazole, 200 mg/5 ml |
+b |
+b |
+b |
| |
tablet, 100 mg, 200 mg |
+b |
+b |
+b |
| |
tablet, 20 mg + sulfamethoxazole, 100 mg |
+b |
+b |
+b |
| |
80 mg + sulfamethoxazole, 400 mg |
+b |
+b |
+b |
tropicamide |
solution (eye drops), 0.5% |
o |
+p+c |
- |
verapamil hydrochloride |
tablet, 40 mg, 80 mg |
+b |
+b |
+b |
warfarin sodium |
tablet, 1 mg, 2 mg, 5 mg |
? |
+b |
+b |
zinc oxide |
cream |
- |
+p+c |
- |
| |
ointment |
- |
+p+c |
- |
1 +: in vivo studies required; +b: bioequivalence studies; +p: pharmacodynamic studies; +c: clinical trials; -: no in vivo studies required;?: decision on the type of in vivo studies pending; o: no information available, no final decision taken, or not available on national market. See also pp. 124-135.
2 "Depot" preparation for injection.
Reference
1. The use of essential drugs. Sixth report of the WHO Expert Committee. Geneva, World Health Organization, 1995 (WHO Technical Report Series, No. 850).
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